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Youth with disabilities face many challenges as they transition from buy kamagra online no prescription high kamagra usa legal school to adulthood. Compared with their nondisabled peers, a greater share of youth with disabilities experience higher rates of poverty, health issues, service needs, dependence on benefits, and poorer academic performance, and they face buy kamagra online no prescription lower expectations for their education and employment achievements. More inclusive attitudes and policies, such as those buy kamagra online no prescription promoted in the Workforce Innovation and Opportunity Act, recognize the value of continued education and work experience for youth with disabilities, and evidence has shown that they can succeed in the workforce with proper supports. As a result, federal and state agencies have bolstered their efforts to better serve youth with disabilities during this critical transition.

One of these initiatives is the Vermont Linking Learning to Careers project, which was made possible by a Disability Innovation Fund grant from the Rehabilitation Services Administration at the U.S buy kamagra online no prescription. Department of Education buy kamagra online no prescription. A newly released impact evaluation of Linking Learning to Careers conducted by Mathematica showed the project had significant improvements on services, education, and, for some students, employment.The Vermont Division of Vocational Rehabilitation sought to improve the college and career readiness of roughly 400 high school students with disabilities by providing a more individualized and targeted approach to help them gain confidence and strategically plan for their futures. Students participating in Linking Learning to Careers received unpaid and paid work-based learning experiences aligned with their individual plans, opportunities for college exploration buy kamagra online no prescription and coursework at the Community College of Vermont, transportation assistance, and access to assistive technology.

The program added staff so that each student had a team providing transition support buy kamagra online no prescription. The program also coincided with a shift at the Division of Vocational Rehabilitation that extended the time frame staff work with participants to go beyond high school graduation into young adulthood and reoriented its service delivery toward a long-term career perspective buy kamagra online no prescription rather than short-term job placement.“Through Linking Learning to Careers, the Vermont Division of Vocational Rehabilitation offered a comprehensive approach to work-based learning tied to other supports, and the evaluation provides strong, promising evidence on the early effects of their model,” said Todd Honeycutt, a Mathematica principal researcher and project director of the evaluation.Mathematica conducted an implementation evaluation to determine whether Linking Learning to Careers was implemented as intended and an impact evaluation to track students’ outcomes for up to two years after they enrolled in the program. Some of the key findings highlighted in the impact report include the following. Linking buy kamagra online no prescription Learning to Careers had a large impact on service use.

It led to a 16 percentage point increase in the share buy kamagra online no prescription of students having two work-based learning experiences, including one paid, and was associated with a 41 percentage point increase in the share of students that had at least one work-based learning experience. There was a large positive impact on enrollment in postsecondary education. The program increased participation in postsecondary education by 8 buy kamagra online no prescription percentage points. The program affected employment buy kamagra online no prescription outcomes for later enrollees but not all participants.

Later enrollees in the program were 11 percentage buy kamagra online no prescription points more likely to have paid employment within 24 months, but the program did not affect employment outcomes for all participants when compared with the control group. The report discusses several reasons for the lack of impact on all participants, including that most youth had not graduated high school by 24 months after enrollment. Vermont’s ability to design and pilot this program and employ the lessons learned from the evaluation supported the Division of Vocational Rehabilitation’s decision to refine its transition program practices buy kamagra online no prescription for youth with disabilities. Hear more about the insights and lessons from Linking Learning to Careers in a video podcast about how Vermont went beyond buy kamagra online no prescription work-based learning experiences in its transition services for youth with disabilities.

Also available is a blog that offers a road map to other state vocational rehabilitation agencies looking to improve their youth programs. Finally, check out a recording of a webinar in which project leaders, evaluation and technical assistance staff, transition team members, and a student participant buy kamagra online no prescription discuss their experiences with Linking Learning to Careers.Magali Sanchez-Hall, a Wilmington resident for over two decades, has struggled with asthma her entire life. She says the health issue stems from her proximity buy kamagra online no prescription to oil and gas drilling.Emma Newburger | CNBCLOS ANGELES, CALIF. €” Stepping out of a coffee shop near Interstate 110 in buy kamagra online no prescription the Wilmington neighborhood of Los Angeles, you're immediately hit by a foul odor.Magali Sanchez-Hall, 51, who's lived here for more than two decades, is used to the smell of rotting eggs wafting from the hundreds of oil wells operating in the neighborhood.

She's used to her neighbors describing chronic coughs, skin rashes and cancer diagnoses, and to the asthma that affects her own family, who live only 1,500 feet from a refinery."When people are getting sick with cancer or having asthma, they might think it's normal or blame genetics," she said. "We don't often look at the environment we're in and think — the chemicals we're breathing are the cause."Wilmington, a predominantly working-class and Latino immigrant community of more than 50,000 people, has some of the highest rates of asthma and cancer in the state, according buy kamagra online no prescription to a report by the non-profit Communities for a Better Environment. It's surrounded by six oil refineries and wedged in by several freeways and buy kamagra online no prescription the ports of L.A. And Long Beach.California, the seventh-largest oil-producing state in the U.S., has no rule or standard for the distance that active oil wells need to be from communities.

For many Californians, especially Black and brown residents, acrid smells, noise and dirt from oil production is part of buy kamagra online no prescription the neighborhood.Walking around Wilmington, pumpjacks are visible in public parks, next to schoolyards where children play and outside of people's windows at home. At night, the sky is lit orange buy kamagra online no prescription from refinery flares.The discovery of oil in the 1920s led to significant population growth in the area. People built and bought houses next to the oil fields and buy kamagra online no prescription refineries, which employ thousands of residents in the area. In L.A.

County, the industry employs about 37,000 people, according to a report by Capitol Matrix Consulting.Oil tanks wedged between homes in the Wilmington neighborhood of Los Angeles.Emma Newburger | CNBCMore than 2 buy kamagra online no prescription million California residents live within 2,500 feet of an operational oil and gas well and another 5 million — 14% of the state's population — are within 1 mile, according to an analysis by the non-profit FracTracker Alliance.Residents are especially vulnerable in L.A. County, which is home to buy kamagra online no prescription the Inglewood Oil Field. The 1,000-acre site is one of the largest urban oil fields in the country and is owned and operated by Sentinel Peak Resources. More than half a million people buy kamagra online no prescription live within a quarter mile of active wells that release hazardous air pollutants like benzene, hydrogen sulfide, particulate matter and formaldehyde.Sentinel Peak did not respond to requests for comment.Sanchez-Hall didn't understand the link between the nearby refineries and the health issues in her community until she left.

She graduated college and pursued a masters degree at UCLA, where she took environmental law classes, and now advocates for clean air and energy in her neighborhood."Wilmington is ground buy kamagra online no prescription zero for pollution," Sanchez-Hall said. "Now I understood why people were dying of cancer around me. We're not disposable buy kamagra online no prescription people. There is a huge disadvantage because many of us don't know what's happening."No buffer zone between drilling and peopleResearch shows that people who live near oil and gas drilling sites are exposed to harmful pollution and are at greater risk of preterm births, asthma, respiratory disease and cancer.Residing buy kamagra online no prescription near oil wells is linked to reduced lung function and wheezing, and in some cases the respiratory damage rivals that of daily exposure to secondhand smoke or living beside a freeway, according to a recent study published in the journal Environmental Research.Another study, published in the journal Environmental Health Perspectives, analyzed nearly 3 million births in California of women living within 6.2 miles of at least one oil or gas well.

The authors buy kamagra online no prescription concluded that living near those wells during pregnancy increased the risk of low-birthweight babies.Environmental advocacy groups have urged California Gov. Gavin Newsom to instate a 2,500-foot buffer zone, or setback, between fossil fuel operations and homes and schools. This year, a bill to ban fracking and instate a buffer zone failed in a state committee vote.Other oil-producing states including Colorado, Pennsylvania, and Texas have already implemented some form of buffer buy kamagra online no prescription zone between properties and wells.In 2019, Newsom ordered his regulators to study such a health-and-safety rule, but they didn't meet the December 2020 deadline for action. State oil regulators also missed a more recent deadline in the spring to release new regulations that would help protect the health and safety of people buy kamagra online no prescription living near drilling sites.

The California Geologic Energy Management Division, which oversees the state's fossil fuel industries, hasn't yet set a new timeline for regulations.Meanwhile, the governor since 2019 has approved roughly 9,014 oil and gas permits, according to an analysis of state data by Consumer Watchdog and FracTracker Alliance."Frontline communities have been waiting for very basic protections from dangerous oil and gas projects for too long," said Hollin Kretzmann, an attorney for the Center for Biological Diversity, which recently sued the state for approving thousands of drilling and fracking projects without the required environmental review."A safety buffer is the bare minimum," Kretzmann said. "The fact that our state continues to delay is frustrating and completely unacceptable."Josiah Edwards, 21, grew up near the largest oil refinery on the buy kamagra online no prescription West Coast. "Oil drilling and refineries were always an ever present background in my life," he said.Emma Newburger | CNBCThe Western States Petroleum Association and the State Building and Construction Trades Council have opposed a statewide mandate to establish buffer zones, arguing that doing so would harm workers and increase fuel costs."A one-size-fits-all approach for an entire state for an issue like this is buy kamagra online no prescription rarely good public policy," said WSPA spokesman Kevin Slagle. "Setback distances not based data specific to a region could lead to significant impacts on communities, jobs and the affordability and reliability of energy in the state."Environmentalists have also called on Newsom to place an immediate moratorium on all new oil and gas permits in those zones.Earlier this year, the governor directed state agencies to halt new fracking permits by 2024 and buy kamagra online no prescription to consider phasing out oil production by 2045.

The announced marked a shift in position by Newsom, who's previously said he doesn't have executive authority to ban fracking, which accounts for just 2% of oil extraction in California, according to the state's Department of Conservation.Newsom's office did not respond to requests for comment.Newsom's predecessor, Jerry Brown, who held office between 2011 and 2018, approved 21,397 new oil wells. More than three-quarters of new wells under Brown's administration are in low-income communities and communities of color, according to state data analyzed by the Center for Biological Diversity.'I could have had a better life'Josiah Edwards, buy kamagra online no prescription 21, grew up in Carson, a city located in the south bay region of Los Angeles and near the West Coast's largest oil refinery, owned by Marathon Petroleum Corp. Edwards and his family members suffered from asthma and were constantly concerned about breathing in emissions of the nearby refineries."Oil drilling and refineries were buy kamagra online no prescription always an ever present background in my life," said Edwards, who now volunteers for the Sunrise Movement, an environmental advocacy group, in Los Angeles.Edwards recalled getting bloody noses as a child and coming to connect them with the pollution from refineries. He dove into research on how exposure to pollution may contribute to the development of asthma in childhood and wondered if his life would have been different growing up elsewhere."It makes me angry and upset.

There's a situation buy kamagra online no prescription where I could have had a better life with improved health outcomes," Edwards said. "Even though it still makes me feel angry, I find a lot of hope in buy kamagra online no prescription what could be. There's a potential for change."Marathon spokesman Jamal Kheiry said the company's refinery in Carson has invested in air emissions control equipment and cut its criteria pollutant emissions by buy kamagra online no prescription 35% in the past decade. It's also invested $25 million to install air monitoring systems along the perimeter of its facilities, and is providing those results to the public.Wilmington Athletic Complex is located beside oil tanks.Emma Newburger | CNBCPhasing out oil and gas locallySome parts of the state have taken matters into their own hands.Culver City in L.A.

County passed an ordinance to phase out oil and gas extraction buy kamagra online no prescription in its portion of the Inglewood Oil Field within five years, in one of the most ambitious moves by an oil-producing jurisdiction. The ordinance also requires that all the wells be plugged and abandoned in that time period.Ventura County, located northwest of L.A., has adopted a 2,500 buffer buy kamagra online no prescription zone between oil wells and schools and 1,500 feet between wells and homes.And L.A. County supervisors voted unanimously earlier this month to phase out oil and gas drilling and ban new drill sites in the unincorporated areas. The county is set to determine the buy kamagra online no prescription quickest way to shut down wells legally before providing a timeline on the phase out.Jacob Roper, a spokesperson for the Department of Conservation, of which CalGEM is a sub-agency, said the department is "hard at work developing a science-based health and safety regulation to protect communities and workers from the impacts of oil extraction activities.""This is a complex set of rules with subject matter outside of our previous regulatory experience," Roper said.

"It involves close collaboration buy kamagra online no prescription with other state agencies and an independent public health expert panel in an effort to ensure a thorough analysis of relevant science and engineering practices."L.A. Could become buy kamagra online no prescription one of the first major cities in the U.S. To nearly phase out fossil fuels from power supply without disruption to the economy, according to a recent study commissioned by the city. Technologies like buy kamagra online no prescription solar farms, wind turbines, batteries and electric vehicles would make the transition possible, while mitigating harmful air pollution in the most vulnerable communities."There are local officials who are taking this issue seriously," Kretzmann said.

"But the fires, ongoing drought and heatwaves in California are stark reminders that we need much bolder action on fossil fuels."People walk at a pedestrian crossing along the Orchard Road shopping district in Singapore on September 7, 2021.Roslan Rahman | AFP | Getty ImagesSINGAPORE — Singapore announced Saturday it will be opening new travel lanes for vaccinated visitors from 8 more countries.It came as its Prime Minister Lee Hsien Loong predicted it will take between three to six months to get to a "new normal" of living with erectile dysfunction treatment.The Southeast Asian country will be launching more buy kamagra online no prescription vaccinated travel lanes (VTL) — with Canada, Denmark, France, Italy, Netherlands, Spain, the U.K. And the U.S., the transport ministry announced."All 8 countries are already open to travelers from Singapore. So the VTLs will restore two-way quarantine-free travel between Singapore and them," Transport Minister S Iswaran said Saturday.We should respect erectile dysfunction treatment, but we must not be paralyzed by fear.Lee Hsien LoongSingapore prime ministerThe initiative allows quarantine-free travel for those who are vaccinated, but travelers buy kamagra online no prescription will have to take erectile dysfunction treatment tests to ensure they are not infected with the kamagra before entering the country.Applications will open on Tuesday, and travelers from those countries who meet the conditions will be able to enter Singapore from Oct. 19, the minister said.Singapore buy kamagra online no prescription announced the initiative with South Korea on Friday.

The city-state already started similar arrangements with Germany and Brunei in September.Living with erectile dysfunction treatmentIn a national address on Saturday, Singapore's leader Lee elaborated on when the "new normal" could occur."How will we know when we get to the buy kamagra online no prescription new normal?. It will be when we can ease off restrictions, have just light [safe management measures] in place, and cases remain stable – perhaps hundreds a day, but not growing," Lee said. "When our hospitals can go back to business as usual, when we can resume doing the things we used to do, and see crowds again without getting worried or feeling strange."He urged the nation not to be "paralyzed by fear," and said that "sooner or later, every one of us will meet the kamagra — this means all the elderly will meet the kamagra too."He said regions like Europe reached this state, but "paid for it dearly" with many lives lost."It will take us at least three months, and perhaps as long as six months to get to this new norm," Lee added.Tightening measures for the unvaccinatedSingapore will also tighten some erectile dysfunction treatment restrictions for the unvaccinated.Those who are buy kamagra online no prescription not vaccinated will no longer be allowed to enter malls, said Gan Kim Yong, Singapore's trade minister and co-chair of the government's erectile dysfunction taskforce, in a briefing Saturday. Even those vaccinated will now be subject to a limit of two people when entering malls, he said.The unvaccinated will also not be allowed to dine-in at coffee shops and food centers — open-air food establishments in the country, where they were previously allowed to do so, limited to two people per table.Singapore's ministry of health said the latest measures were aimed at protecting those who were more vulnerable, such as the unvaccinated and the elderly.Those restrictions will kick in on Wednesday.Singapore's erectile dysfunction treatment strategySingapore buy kamagra online no prescription had maintained a zero-erectile dysfunction treatment strategy for the most part of the kamagra, but started opening up after the population's vaccination rate hit more than 80%.

As of Oct. 7, 83% of the population has completed two doses of buy kamagra online no prescription a erectile dysfunction treatment.But after loosening restrictions, the number of cases started spiking, reaching daily record highs and hovering above 3,400 in the last few days.Authorities in Singapore last month tightened erectile dysfunction treatment measures again in a bid to slow community transmissions and protect hospitals from being overwhelmed. They reduced group sizes for social gatherings buy kamagra online no prescription from five to two, and set working from home as the default, encouraging the vulnerable population such as the elderly to stay home as much as possible.As of Friday, the total number of s stands at 120,454, with 142 deaths. However, 98.4% of infected people over the past 28 days had no symptoms or mild symptoms, according to the country's health ministry..

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HarvoniEpclusaVosevi 2013-12-13 2019-12-13 N/A 2021-12-13 solriamfetol hydrochloride 237511 Sunosi Jazz Pharmaceuticals Ireland Ltd. N/A 2021-05-13 2027-05-13 kamagra oral jelly best price N/A 2029-11-13 sonidegib phosphate 229407 Odomzo Sun Pharma Global FZE N/A 2020-06-12 2026-06-12 N/A 2028-06-12 stiripentol 142417 Diacomit Biocodex SA N/A 2012-12-21 2018-12-21 Yes 2021-06-21 sucroferric oxyhydroxide 201492 Velphoro Vifor Fresenius Medical Care Renal Pharma Ltd. N/A 2018-01-05 2024-01-05 N/A 2026-01-05 sugammadex sodium 180385 Bridion Merck Canada Inc. N/A 2016-02-05 2022-02-05 N/A 2024-02-05 suvorexant 196367 Belsomra Merck Canada Inc. N/A 2018-11-29 2024-11-29 N/A 2026-11-29 tafamidis meglumine 228368 Vyndaqel Pfizer Canada ULC N/A 2020-01-20 2026-01-20 N/A 2028-01-20 tafluprost 165596 Saflutan Purdue Pharma N/A 2014-05-26 2020-05-26 N/A 2022-05-26 talazoparib (supplied as kamagra oral jelly best price talazoparib tosylate) 220584 Talzenna Pfizer Canada ULC N/A 2019-09-06 2025-09-06 N/A 2027-09-06 taliglucerase alfa 140854 Elelyso Pfizer Canada Inc.

N/A 2014-05-29 2020-05-29 Yes 2022-11-29 tedizolid phosphate 173603 Sivextro Merck Canada Inc. N/A 2015-03-17 2021-03-17 N/A 2023-03-17 teduglutide 180223 Revestive Takeda kamagra oral jelly best price Canada Inc. N/A 2015-09-04 2021-09-04 Yes 2024-03-04 telotristat ethyl (as telotristat etiprate) 208730 Xermelo Ipsen Biopharmaceuticals Canada Inc. N/A 2018-10-10 2024-10-10 N/A 2026-10-10 tenapanor hydrochloride 224850 Ibsrela Knight Therapeutics Inc. N/A 2020-04-15 2026-04-15 N/A 2028-04-15 tenofovir alafenamide hemifumarate 181399 Genvoya Gilead kamagra oral jelly best price Sciences Canada Inc.

DescovyOdefseyVemlidySymtuzaBiktarvy 2015-11-27 2021-11-27 Yes 2024-05-27 teriflunomide 160646 Aubagio Genzyme Canada a division of Sanofi-aventis Canada Inc. N/A 2013-11-14 2019-11-14 Yes 2022-05-14 tesamorelin 131836 Egrifta Theratechnologies Inc. N/A 2014-04-29 2020-04-29 N/A 2022-04-29 tezacaftor 211292 Symdeko Vertex Pharmaceuticals (Canada) Incorporated N/A 2018-06-27 2024-06-27 Yes 2026-12-27 tisagenlecleucel 213547 / 213698 Kymriah Novartis Pharmaceuticals Canada Inc. N/A 2018-09-05 2024-09-05 Yes 2027-03-05 tofacitinib 154642 Xeljanz Pfizer Canada Inc. N/A 2014-04-17 2020-04-17 Yes 2022-10-17 trametinib 157665 Mekinist Novartis Pharmaceuticals Canada Inc.

N/A 2013-07-18 2019-07-18 N/A 2021-07-18 trastuzumab deruxtecan 242104 Enhertu AstraZeneca Canada Inc. N/A 2021-04-15 2027-04-15 N/A 2029-04-15 trastuzumab emtansine 162414 Kadcyla Hoffmann-La Roche Limited N/A 2013-09-11 2019-09-11 N/A 2021-09-11 trifarotene 221945 Aklief Galderma Canada Inc. N/A 2019-11-25 2025-11-25 Yes 2028-05-25 tipiracil hydrochloride 205852 Lonsurf Taiho Pharma Canada Inc. N/A 2018-01-25 2024-01-25 N/A 2026-01-25 triheptanoin 242196 Dojolvi Uagenyx Pharmaceutical Inc. N/A 2021-02-15 2027-02-15 Yes 2029-08-15 tucatinib 235295 Tukysa Seattle Genetics Inc.

N/A 2020-06-05 2026-06-05 N/A 2028-06-05 turoctocog alfa 170796 Zonovate Novo Nordisk Canada Inc. N/A 2014-12-08 2020-12-08 Yes 2023-06-08 ulipristal acetate 156861 Fibristal Allergan Inc. N/A 2013-06-24 2019-06-24 N/A 2021-06-24 umeclidinium bromide 161585 Anoro Ellipta GlaxoSmithKline Inc. Incruse Ellipta 2013-12-23 2019-12-23 N/A 2021-12-23 upadacitinib 223734 Rinvoq AbbVie Corporation N/A 2019-12-23 2025-12-23 N/A 2027-12-23 varicella-zoster kamagra glycoprotein E (gE) 200244 Shingrix GlaxoSmithKline Inc. N/A 2017-10-13 2023-10-13 N/A 2025-10-13 vedolizumab 169414 Entyvio Takeda Canada Inc.

N/A 2015-01-29 2021-01-29 Yes 2023-07-29 velpatasvir 190521 Epclusa Gilead Sciences Canada Inc. Vosevi 2016-07-11 2022-07-11 Yes 2025-01-11 venetoclax 190761 Venclexta AbbVie Corporation N/A 2016-09-30 2022-09-30 N/A 2024-09-30 vernakalant hydrochloride 190817 Brinavess Cipher Pharmaceuticals Inc. N/A 2017-03-13 2023-03-13 N/A 2025-03-13 vilanterol trifenatate 157301 Breo Ellipta GlaxoSmithKline Inc. Anoro ElliptaTrelegy Ellipta 2013-07-03 2019-07-03 Yes 2022-01-03 vilazodone hydrochloride 176820 Viibryd Allergan Inc. N/A 2015-07-16 2021-07-16 Yes 2024-01-16 vismodegib 154608 Erivedge Hoffmann-La Roche Ltd.

N/A 2013-07-12 2019-07-12 N/A 2021-07-12 von willebrand factor (recombinant) (vonicog alfa) 213188 Vonvendi Takeda Canada Inc. N/A 2019-01-10 2025-01-10 N/A 2027-01-10 vorapaxar sulfate 179320 Zontivity Toprol Acquisition LLC N/A 2016-05-13 2022-05-13 N/A 2024-05-13 voretigene neparvovec 233097 Luxturna Novartis Pharmaceuticals Canada Inc. N/A 2020-10-13 2026-10-13 Yes 2029-04-13 vortioxetine hydrobromide 159019 Trintellix Lundbeck Canada Inc. N/A 2014-10-22 2020-10-22 Yes 2023-04-22 voxilaprevir 202324 Vosevi Gilead Sciences Canada Inc. N/A 2017-08-16 2023-08-16 N/A 2025-08-16 zanubrutinib 242748 Brukinsa BeiGene Switzerland GmbH N/A 2021-03-01 2027-03-01 N/A 2029-03-01The fee as of April 1, 2021 is $9,756 Register of Certificates of Supplementary Protection and Applications Guidance Document.

Certificate of Supplementary Protection Regulations - summary Notice. Publication of update to the Guidance Document. Certificate of Supplementary Protection Regulations CSP Application Form (effective January 6, 2021) CSP Application Form (effective April 1, 2020 to January 5, 2021) CSP Application Form (effective May 15, 2019 to March 31, 2020) CSP Application Form (effective September 22, 2018 to May 14, 2019) CSP Application Form (from September 21, 2017 to September 21, 2018) Advance Payment Details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications How to Pay Fees to Health Products and Food Branch (HPFB) Background Register of Certificates of Supplementary Protection and Applications Certificates of Supplementary Protection and Applications - Human Use Certificate of Supplementary Protection (CSP) and/or Application Number Medicinal Ingredient(s) New Drug Submission (NDS) Number Patent Number Patent Expiry Dateyyyy-mm-dd Application Status CSP Term Beginsyyyy-mm-dd CSP Term Endsyyyy-mm-dd 900039 abemaciclib 215268 2747055 2029-12-15 Issued 2029-12-16 2031-12-15 900045 acalabrutinib 214504 2841886 2032-07-11 Issued 2032-07-12 2034-07-11 900056 alpelisib 226941 2734819 2029-09-08 Issued 2029-09-09 2031-09-08 900035 antihemophilic factor (recombinant, B-domain deleted, pegylated) (also known as damoctocog alfa pegol) 210935 2586379 2025-11-14 Issued 2025-11-15 2027-11-14 900027 apalutamide 211942 2875767 2033-06-04 Issued 2033-06-05 2033-07-04 900026 baricitinib 193687 2718271 2029-03-10 Issued 2029-03-11 2031-03-10 900012 benralizumab 204008 2685222 2028-05-14 Issued 2028-05-15 2030-05-14 900028 bictegravir sodium / emtricitabine / tenofovir alafenamide hemifumarate 203718 2416757 2021-07-20 Refused 900020 brigatinib 210369 2723961 2029-05-21 Issued 2029-05-22 2031-05-21 900015 brodalumab 195317 2663537 2027-10-01 Issued 2027-10-02 2029-10-01 900060 brolucizumab 226224 2727839 2029-06-25 Issued 2029-06-26 2031-06-25 900057 cabotegravir (cabotegravir sodium) 227315 2606282 2026-04-28 Issued 2026-04-29 2028-04-28 900063 cedazuridine / decitabine 234610 2702274 2028-10-16 Issued 2028-10-17 2030-10-16 900022 cenegermin 218145 2346257 2019-10-11 Refused 900011 coagulation factor IX (recombinant), pegylated 201114 2462930 2022-10-09 Refused 900052 coagulation factor IX (recombinant), pegylated 201114 2665480 2027-10-04 Refused 900019 crisaborole 206906 2597982 2026-02-16 Issued 2026-02-17 2028-02-16 900041 dacomitinib 214572 2565812 2025-04-25 Issued 2025-04-26 2027-04-25 900058 darolutamide 226146 2777896 2030-10-27 Issued 2030-10-28 2032-10-27 900017 darunavir ethanolate / cobicistat / emtricitabine / tenofovir alafenamide hemifumarate 199705 2678907 2028-02-22 Issued 2028-02-23 2030-02-22 900051 dolutegravir (dolutegravir sodium) / lamivudine 220275 3003988 2031-01-24 Issued 2031-01-25 2033-01-24 900021 dolutegravir (dolutegravir sodium) / rilpivirine (rilpivirine hydrochloride) 206402 2606282 2026-04-28 Refused 900034 doravirine 211293 2794377 2031-03-28 Issued 2031-03-29 2033-03-28 900004 dupilumab 201285 2737044 2029-10-27 Issued 2029-10-28 2031-10-27 900010 durvalumab 202953 2778714 2030-11-24 Issued 2030-11-25 2032-11-04 900024 emicizumab 212635 2817964 2031-11-17 Issued 2031-11-18 2033-08-03 900053 entrectinib 227517 2693901 2028-07-08 Issued 2028-07-09 2030-07-08 900074 eptinezumab 233288 2836649 2032-05-21 Pending 900070 erdafitinib 224529 2796204 2031-04-28 Issued 2031-04-29 2033-04-28 900025 erenumab 208607 2746858 2029-12-18 Issued 2029-12-19 2031-12-18 900018 ertugliflozin 204724 2733795 2029-08-17 Issued 2029-08-18 2031-08-17 900076 estetrol monohydrate / drospirenone 236197 2448278 2022-05-23 Pending 900033 fluticasone furoate, umeclidinium (as bromide), vilanterol (as trifenatate) 204880 2781487 2030-11-29 Issued 2030-11-30 2032-11-29 900044 galcanezumab 219521 2802102 2031-06-07 Issued 2031-06-08 2033-06-07 900055 gilteritinib fumarate 227918 2760061 2030-05-06 Issued 2030-05-07 2032-05-06 900062 glasdegib 225793 2690953 2028-06-16 Issued 2028-06-17 2030-06-16 900001 glecaprevir / pibrentasvir 202233 2807847 2031-10-12 Refused 900014 glycopyrronium (as bromide) / formoterol fumarate dihydrate 201306 2763936 2030-05-28 Refused 900003 guselkumab 200590 2635692 2026-12-28 Issued 2026-12-29 2028-12-28 900032 inotersen (inotersen sodium) 214274 2797792 2031-04-29 Issued 2031-04-30 2033-04-29 900023 insulin glargine / lixisenatide 207006 2740685 2029-10-09 Issued 2029-10-10 2031-10-09 900029 lanadelumab 213920 2786019 2031-01-06 Issued 2031-01-07 2033-01-06 900043 larotrectinib (larotrectinib sulfate) 219998 2741313 2029-10-21 Issued 2029-10-22 2031-10-21 900066 lefamulin (supplied as lefamulin acetate) 233292 2678795 2028-03-19 Issued 2028-03-20 2030-03-19 900069 lemborexant 231286 2811895 2031-09-20 Issued 2031-09-21 2033-09-20 900007 letermovir 204165 2524069 2024-04-17 Issued 2024-04-18 2026-04-17 900009 lifitegrast 199810 2609053 2026-05-17 Issued 2026-05-18 2028-05-17 900040 lorlatinib 215733 2863892 2033-02-20 Issued 2033-02-21 2034-02-23 900071 luspatercept 236441 2733911 2029-08-13 Issued 2029-08-14 2031-08-13 900002 neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily A / neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily B 195550 2463476 2022-10-11 Issued 2022-10-12 2024-10-11 900008 olaratumab 203478 2680945 2026-06-19 Issued 2026-06-20 2028-06-19 900072 ozanimod (ozanimod hydrochloride) 232761 2723904 2029-05-14 Issued 2029-05-15 2031-05-14 900073 ozanimod (ozanimod hydrochloride) 232761 2780772 2030-11-15 Withdrawn 900067 polatuzumab vedotin 232303 2693255 2028-07-15 Issued 2028-07-16 2030-07-15 900050 prasterone 198822 2696127 2028-08-08 Withdrawn 900068 remdesivir 240551 2804840 2031-07-22 Issued 2031-07-23 2033-07-22 900016 ribociclib (ribociclib succinate) 203884 2734802 2029-08-20 Issued 2029-08-21 2031-08-20 900065 ripretinib 234688 2875970 2032-06-07 Issued 2032-06-08 2034-06-07 900042 risankizumab 215753 2816950 2031-11-02 Issued 2031-11-03 2033-11-02 900031 rivaroxaban 211611 2451258 2022-06-07 Pending 900046 romosozumab 197713 2607197 2026-04-28 Issued 2026-04-29 2028-04-28 900061 satralizumab 233642 2699834 2029-09-25 Issued 2029-09-26 2031-09-25 900005 semaglutide 202059 2601784 2026-03-20 Issued 2026-03-21 2028-03-20 900054 siponimod 223225 2747437 2029-12-16 Withdrawn 900059 siponimod 223225 2747992 2029-12-21 Issued 2029-12-22 2031-12-21 900038 suvorexant 160233 2670892 2027-11-30 Refused 900048 talazoparib (talazoparib tosylate) 220584 2732797 2029-07-27 Issued 2029-07-28 2031-07-27 900036 tezacaftor / Ivacaftor 211292 2742821 2028-11-12 Issued 2028-11-13 2030-11-12 900030 tisagenlecleucel 213547 2820681 2031-12-09 Issued 2031-12-10 2033-12-09 900064 tucatinib 235295 2632194 2026-11-15 Issued 2026-11-16 2028-11-15 900049 upadacitinib 223734 2781891 2030-12-01 Issued 2030-12-02 2032-12-01 900006 varicella-zoster kamagra glycoprotein E (gE) 200244 2600905 2026-03-01 Refused 900075 zanubrutinib 242748 2902686 2034-04-22 Pending Certificates of Supplementary Protection and Applications - Veterinary Use Certificate of Supplementary Protection (CSP) and/orApplication Number Medicinal Ingredient(s) New Drug Submission (NDS) Number Patent Number Patent Expiry Dateyyyy-mm-dd Application Status CSP Term Beginsyyyy-mm-dd CSP Term Endsyyyy-mm-dd 900013 lotilaner 193712 2747354 2029-12-17 Issued 2029-12-18 2031-12-17 900047 sarolaner/moxidectin/pyrantel (as pyrantel pamoate) 210868 2882200 2033-09-04 Issued 2033-09-05 2034-09-27 900037 sarolaner / selamectin 190913 2828397 2032-02-23 Issued 2032-02-24 2033-11-07 BackgroundThe Register of Certificates of Supplementary Protection (CSP) and Applications is maintained pursuant to the Certificate of Supplementary Protection Regulations and the Patent Act. The register includes information from CSPs and CSP applications. Under the subsection 115(1) of the Patent Act, the issuance of a CSP grants the certificate's holder and their legal representatives the same legal rights, privileges and liberties that are granted by the patent set out in the certificate, but only with respect to the making, constructing, using and selling of any drug that contains the medicinal ingredient, or combination of medicinal ingredients.The format of the register is an electronic table.

The register lists, in alphabetical order, the medicinal ingredient(s) in the CSPs and CSP applications.Information regarding the patent set out in the CSP or CSP application is available at the Canadian Intellectual Property Office.For comments or questions, or to obtain a copy of a CSP or CSP application details, please contact the Office of Patented Medicines and Liaison by email at hc.opml-bmbl.sc@canada.ca or by telephone at 613-941-7281..

Abemaciclib 215268 Can you buy over the counter kamagra Verzenio Eli Lilly Canada buy kamagra online no prescription Inc. N/A 2019-04-08 2025-04-08 N/A 2027-04-08 acalabrutinib 214504 Calquence AstraZeneca Canada Inc. N/A 2019-08-23 2025-08-23 N/A 2027-08-23 aclidinium bromide 157598 Tudorza Genuair AstraZeneca Canada Inc buy kamagra online no prescription. Duaklir Genuair 2013-07-29 2019-07-29 N/A 2021-07-29 afatinib dimaleate 158730 Giotrif Boehringer Ingelheim (Canada) Ltd.

N/A 2013-11-01 2019-11-01 N/A 2021-11-01 aflibercept 149321 Eylea Bayer Inc. N/A 2013-11-08 2019-11-08 N/A buy kamagra online no prescription 2021-11-08 albiglutide 165145 Eperzan GlaxoSmithKline Inc. N/A 2015-07-15 2021-07-15 N/A 2023-07-15 alectinib hydrochloride 189442 Alecensaro Hoffmann-La Roche Limited N/A 2016-09-29 2022-09-29 N/A 2024-09-29 alirocumab 183116 Praluent Sanofi-aventis Canada Inc. N/A 2016-04-11 2022-04-11 N/A 2024-04-11 alogliptin benzoate 158335 Nesina Takeda Canada Inc.

KazanoOseni 2013-11-27 2019-11-27 N/A 2021-11-27 alpelisib 226941 Piqray Novartis Pharmaceuticals buy kamagra online no prescription Canada Inc. N/A 2020-03-11 2026-03-11 N/A 2028-03-11 amifampridine (supplied as amifampridine phosphate) 232685 Firdapse Kye Pharmaceuticals Inc. N/A 2020-07-31 2026-07-31 N/A 2028-07-31 anthrax immune globulin (human) 200446 Anthrasil Emergent BioSolutions Canada Inc. N/A 2017-11-06 2023-11-06 Yes 2026-05-06 antihemophilic factor (recombinant buy kamagra online no prescription BDD), Fc fusion protein 163447 Eloctate Sanofi-Aventis Canada Inc.

N/A 2014-08-22 2020-08-22 Yes 2023-02-22 antihemophilic factor (recombinant), pegylated 189709 Adynovate Takeda Canada Inc. N/A 2016-11-17 2022-11-17 Yes 2025-05-17 antihemophilic factor (recombinant, B-domain deleted, pegylated) (also known as damoctocog alfa pegol) 210935 Jivi Bayer Inc. N/A 2018-10-18 2024-10-18 Yes 2027-04-18 antihemophilic factor (recombinant, B-domain deleted) (also known as simoctocog alfa) 169551 Nuwiq Octapharma Pharmazeutika Produktionsges.m.b.H N/A 2014-10-23 buy kamagra online no prescription 2020-10-23 Yes 2023-04-23 antihemophilic factor VIII (recombinant), singlechain (also known as lonoctocog alfa) 190891 Afstyla CSL Behring Canada Inc. N/A 2016-12-12 2022-12-12 Yes 2025-06-12 anthrax antigen fiate 212387 Biothrax Emergent Biodefense Operations Lansing LLC N/A 2018-12-13 2024-12-13 N/A 2026-12-13 antihemophilic factor VIII (recombinant, B-domain truncated), PEGylated (turoctocog alfa pegol) 218531 Esperoct Novo Nordisk Canada Inc.

N/A 2019-07-04 2025-07-04 Yes 2028-01-04 apalutamide 211942 Erleada Janssen Inc. N/A 2018-07-03 2024-07-03 buy kamagra online no prescription N/A 2026-07-03 apremilast 169862 Otezla Amgen Canada Inc. N/A 2014-11-12 2020-11-12 N/A 2022-11-12 asfotase alfa 179340 Strensiq Alexion Pharma International Sàrl N/A 2015-08-14 2021-08-14 Yes 2024-02-14 asunaprevir 172617 Sunvepra Bristol-Myers Squibb Canada N/A 2016-03-09 2022-03-09 N/A 2024-03-09 atezolizumab 196843 Tecentriq Hoffmann-La Roche Limited N/A 2017-04-12 2023-04-12 N/A 2025-04-12 avelumab 204052 Bavencio EMD Serono, a Division of EMD Inc., Canada N/A 2017-12-18 2023-12-18 N/A 2025-12-18 axicabtagene ciloleucel 218389 Yescarta Gilead Sciences Canada Inc N/A 2019-02-13 2025-02-13 N/A 2027-02-13 azelastine hydrochloride 169604 Dymista Meda Pharmaceuticals Ltd. N/A 2014-10-23 2020-10-23 Yes 2023-04-23 baloxavir marboxil buy kamagra online no prescription 227361 Xofluza Hoffmann-La Roche Limited N/A 2020-02-19 2026-02-19 Yes 2028-08-19 baricitinib 193687 Olumiant Eli Lilly Canada Inc.

N/A 2018-08-17 2024-08-17 N/A 2026-08-17 bazedoxifene acetate 160681 Duavive Pfizer Canada Inc. N/A 2014-10-23 2020-10-23 N/A 2022-10-23 benralizumab 204008 Fasenra AstraZeneca Canada Inc. N/A 2018-02-22 2024-02-22 Yes 2026-08-22 bepotastine besilate 179294 Bepreve buy kamagra online no prescription Bausch and Lomb Incorporated N/A 2016-07-27 2022-07-27 Yes 2025-01-27 bictegravir 203718 Biktarvy Gilead Sciences Canada, Inc. N/A 2018-07-10 2024-07-10 Yes 2027-01-10 bilastine 184231 Blexten Aralez Pharmaceutials Canada Inc.

N/A 2016-04-21 2022-04-21 Yes 2024-10-21 binimetinib 237410 Mektovi Pfizer Canada ULC N/A 2021-03-02 2027-03-02 N/A 2029-03-02 blinatumomab 181723 Blincyto Amgen Canada Incorporated N/A 2015-12-22 2021-12-22 Yes 2024-06-22 bosutinib 152211 Bosulif Pfizer Canada Inc. N/A 2014-03-07 2020-03-07 N/A 2022-03-07 botulism antitoxin heptavalen C/ D/ F/ G - (equine) 190645 Bat Emergent buy kamagra online no prescription BioSolutions Inc. N/A 2016-12-08 2022-12-08 Yes 2025-06-08 brexpiprazole 192684 Rexulti Otsuka Pharmaceutical Co. Ltd.

N/A 2017-02-16 2023-02-16 Yes 2025-08-16 brigatinib 210369 Alunbrig Takeda Canada Incorporated N/A 2018-07-26 2024-07-26 N/A 2026-07-26 brivaracetam 183355 Brivlera buy kamagra online no prescription UCB Canada Incorporated N/A 2016-03-09 2022-03-09 Yes 2024-09-09 brodalumab 195317 Siliq Bausch Health, Canada Inc. N/A 2018-03-06 2024-03-06 N/A 2026-03-06 brolucizumab 226224 Beovu Novartis Pharmaceuticals Canada Inc. N/A 2020-03-12 2026-03-12 N/A 2028-03-12 bromfenac sodium sesquihydrate 171657 Prolensa Bausch &. Lomb Incorporated N/A 2015-03-26 buy kamagra online no prescription 2021-03-26 N/A 2023-03-26 burosumab 216239 Crysvita Kyowa Kirin Limited N/A 2018-12-05 2024-12-05 Yes 2027-06-05 cabotegravir sodium 227315 Vocabria ViiV Healthcare ULC N/A 2020-03-18 2026-03-18 N/A 2028-03-18 cabotegravir 227315 Cabenuva ViiV Healthcare ULC N/A 2020-03-18 2026-03-18 N/A 2028-03-18 cabozantinib (supplied as cabozantinib (S)-malate) 206230 Cabometyx Ipsen Biopharmaceuticals Canada Inc.

N/A 2018-09-14 2024-09-14 N/A 2026-09-14 calcifediol 205392 Rayaldee Vifor Fresenius Medical Care Renal Pharma Ltd N/A 2018-07-10 2024-07-10 N/A 2026-07-10 canagliflozin 157505 Invokana Janssen Inc. InvokametInvokamet XR 2014-05-23 2020-05-23 N/A 2022-05-23 caplacizumab 230001 Cablivi Sanofi-Aventis Canada Inc. N/A 2020-02-28 2026-02-28 N/A 2028-02-28 carfilzomib buy kamagra online no prescription 184479 Kyprolis Amgen Canada Inc. N/A 2016-01-15 2022-01-15 N/A 2024-01-15 carglumic acid 171358 Carbaglu Recordati Rare Diseases N/A 2015-04-10 2021-04-10 Yes 2023-10-10 cedazuridine 234610 Inqovi Otsuka Pharmaceutical Co., Ltd.

N/A 2020-07-07 2026-07-07 N/A 2028-07-07 ceftolozane 178006 Zerbaxa buy kamagra online no prescription Merck Canada Inc. N/A 2015-09-30 2021-09-30 N/A 2023-09-30 cemiplimab 218718 Libtayo Sanofi-Aventis Canada Inc. N/A 2019-04-10 2025-04-10 N/A 2027-04-10 cenegermin 218145 Oxervate Dompé farmaceutici S.p.A. N/A 2019-02-08 2025-02-08 N/A 2027-02-08 ceritinib 175702 Zykadia Novartis Pharmaceuticals Canada Inc buy kamagra online no prescription.

N/A 2015-03-27 2021-03-27 N/A 2023-03-27 cerliponase alfa 216539 Brineura Biomarin International Limited N/A 2018-12-19 2024-12-19 Yes 2027-06-19 coagulation factor IX (recombinant), albumin fusion protein (rIX-FP) 180793 Idelvion CSL Behring Canada Inc. N/A 2016-01-26 2022-01-26 Yes 2024-07-26 coagulation factor IX (recombinant), pegylated (nonacog beta pegol) 201114 Rebinyn Novo Nordisk Canada Inc. N/A 2017-11-29 2023-11-29 Yes 2026-05-29 coagulation buy kamagra online no prescription factor IX, Fc fusion protein 163614 Alprolix Sanofi-Aventis Canada Inc. N/A 2014-03-20 2020-03-20 Yes 2022-09-20 cobimetinib 182788 Cotellic Hoffmann-La Roche Limited N/A 2016-02-22 2022-02-22 N/A 2024-02-22 crisaborole 206906 Eucrisa Pfizer Canada Inc.

N/A 2018-06-07 2024-06-07 Yes 2026-12-07 cysteamine bitartrate 191347 Procysbi Horizon Pharma Ireland Ltd. N/A 2017-06-13 2023-06-13 Yes 2025-12-13 dabrafenib mesylate 157590 Tafinlar buy kamagra online no prescription Novartis Pharmaceuticals Canada Inc. N/A 2013-07-16 2019-07-16 N/A 2021-07-16 daclatasvir 172616 Daklinza Bristol-Myers Squibb Canada N/A 2015-08-13 2021-08-13 N/A 2023-08-13 daclizumab beta 190458 Zinbryta Biogen Canada Inc. N/A 2016-12-08 2022-12-08 N/A 2024-12-08 dacomitinib 214572 Vizimpro Pfizer Canada Inc.

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N/A 2021-05-13 2027-05-13 N/A 2029-11-13 sonidegib phosphate 229407 Odomzo Sun Pharma Global FZE N/A buy kamagra online no prescription 2020-06-12 2026-06-12 N/A 2028-06-12 stiripentol 142417 Diacomit Biocodex SA N/A 2012-12-21 2018-12-21 Yes 2021-06-21 sucroferric oxyhydroxide 201492 Velphoro Vifor Fresenius Medical Care Renal Pharma Ltd. N/A 2018-01-05 2024-01-05 N/A 2026-01-05 sugammadex sodium 180385 Bridion Merck Canada Inc. N/A 2016-02-05 2022-02-05 N/A 2024-02-05 suvorexant 196367 Belsomra Merck Canada Inc. N/A 2018-11-29 2024-11-29 N/A 2026-11-29 tafamidis meglumine 228368 Vyndaqel Pfizer Canada ULC N/A 2020-01-20 2026-01-20 N/A 2028-01-20 tafluprost 165596 Saflutan Purdue Pharma N/A 2014-05-26 2020-05-26 N/A 2022-05-26 talazoparib (supplied as talazoparib tosylate) 220584 Talzenna Pfizer Canada ULC N/A buy kamagra online no prescription 2019-09-06 2025-09-06 N/A 2027-09-06 taliglucerase alfa 140854 Elelyso Pfizer Canada Inc.

N/A 2014-05-29 2020-05-29 Yes 2022-11-29 tedizolid phosphate 173603 Sivextro Merck Canada Inc. N/A 2015-03-17 2021-03-17 N/A 2023-03-17 teduglutide 180223 buy kamagra online no prescription Revestive Takeda Canada Inc. N/A 2015-09-04 2021-09-04 Yes 2024-03-04 telotristat ethyl (as telotristat etiprate) 208730 Xermelo Ipsen Biopharmaceuticals Canada Inc. N/A 2018-10-10 2024-10-10 N/A 2026-10-10 tenapanor hydrochloride 224850 Ibsrela Knight Therapeutics Inc.

N/A 2020-04-15 2026-04-15 N/A 2028-04-15 tenofovir alafenamide hemifumarate buy kamagra online no prescription 181399 Genvoya Gilead Sciences Canada Inc. DescovyOdefseyVemlidySymtuzaBiktarvy 2015-11-27 2021-11-27 Yes 2024-05-27 teriflunomide 160646 Aubagio Genzyme Canada a division of Sanofi-aventis Canada Inc. N/A 2013-11-14 2019-11-14 Yes 2022-05-14 tesamorelin 131836 Egrifta Theratechnologies Inc. N/A 2014-04-29 2020-04-29 N/A 2022-04-29 tezacaftor 211292 Symdeko Vertex Pharmaceuticals (Canada) Incorporated N/A 2018-06-27 2024-06-27 Yes 2026-12-27 tisagenlecleucel 213547 / 213698 Kymriah Novartis Pharmaceuticals Canada Inc.

N/A 2018-09-05 2024-09-05 Yes 2027-03-05 tofacitinib 154642 Xeljanz Pfizer Canada Inc. N/A 2014-04-17 2020-04-17 Yes 2022-10-17 trametinib 157665 Mekinist Novartis Pharmaceuticals Canada Inc. N/A 2013-07-18 2019-07-18 N/A 2021-07-18 trastuzumab deruxtecan 242104 Enhertu AstraZeneca Canada Inc. N/A 2021-04-15 2027-04-15 N/A 2029-04-15 trastuzumab emtansine 162414 Kadcyla Hoffmann-La Roche Limited N/A 2013-09-11 2019-09-11 N/A 2021-09-11 trifarotene 221945 Aklief Galderma Canada Inc.

N/A 2019-11-25 2025-11-25 Yes 2028-05-25 tipiracil hydrochloride 205852 Lonsurf Taiho Pharma Canada Inc. N/A 2018-01-25 2024-01-25 N/A 2026-01-25 triheptanoin 242196 Dojolvi Uagenyx Pharmaceutical Inc. N/A 2021-02-15 2027-02-15 Yes 2029-08-15 tucatinib 235295 Tukysa Seattle Genetics Inc. N/A 2020-06-05 2026-06-05 N/A 2028-06-05 turoctocog alfa 170796 Zonovate Novo Nordisk Canada Inc.

N/A 2014-12-08 2020-12-08 Yes 2023-06-08 ulipristal acetate 156861 Fibristal Allergan Inc. N/A 2013-06-24 2019-06-24 N/A 2021-06-24 umeclidinium bromide 161585 Anoro Ellipta GlaxoSmithKline Inc. Incruse Ellipta 2013-12-23 2019-12-23 N/A 2021-12-23 upadacitinib 223734 Rinvoq AbbVie Corporation N/A 2019-12-23 2025-12-23 N/A 2027-12-23 varicella-zoster kamagra glycoprotein E (gE) 200244 Shingrix GlaxoSmithKline Inc. N/A 2017-10-13 2023-10-13 N/A 2025-10-13 vedolizumab 169414 Entyvio Takeda Canada Inc.

N/A 2015-01-29 2021-01-29 Yes 2023-07-29 velpatasvir 190521 Epclusa Gilead Sciences Canada Inc. Vosevi 2016-07-11 2022-07-11 Yes 2025-01-11 venetoclax 190761 Venclexta AbbVie Corporation N/A 2016-09-30 2022-09-30 N/A 2024-09-30 vernakalant hydrochloride 190817 Brinavess Cipher Pharmaceuticals Inc. N/A 2017-03-13 2023-03-13 N/A 2025-03-13 vilanterol trifenatate 157301 Breo Ellipta GlaxoSmithKline Inc. Anoro ElliptaTrelegy Ellipta 2013-07-03 2019-07-03 Yes 2022-01-03 vilazodone hydrochloride 176820 Viibryd Allergan Inc.

N/A 2015-07-16 2021-07-16 Yes 2024-01-16 vismodegib 154608 Erivedge Hoffmann-La Roche Ltd. N/A 2013-07-12 2019-07-12 N/A 2021-07-12 von willebrand factor (recombinant) (vonicog alfa) 213188 Vonvendi Takeda Canada Inc. N/A 2019-01-10 2025-01-10 N/A 2027-01-10 vorapaxar sulfate 179320 Zontivity Toprol Acquisition LLC N/A 2016-05-13 2022-05-13 N/A 2024-05-13 voretigene neparvovec 233097 Luxturna Novartis Pharmaceuticals Canada Inc. N/A 2020-10-13 2026-10-13 Yes 2029-04-13 vortioxetine hydrobromide 159019 Trintellix Lundbeck Canada Inc.

N/A 2014-10-22 2020-10-22 Yes 2023-04-22 voxilaprevir 202324 Vosevi Gilead Sciences Canada Inc. N/A 2017-08-16 2023-08-16 N/A 2025-08-16 zanubrutinib 242748 Brukinsa BeiGene Switzerland GmbH N/A 2021-03-01 2027-03-01 N/A 2029-03-01The fee as of April 1, 2021 is $9,756 Register of Certificates of Supplementary Protection and Applications Guidance Document. Certificate of Supplementary Protection Regulations - summary Notice. Publication of update to the Guidance Document.

Certificate of Supplementary Protection Regulations CSP Application Form (effective January 6, 2021) CSP Application Form (effective April 1, 2020 to January 5, 2021) CSP Application Form (effective May 15, 2019 to March 31, 2020) CSP Application Form (effective September 22, 2018 to May 14, 2019) CSP Application Form (from September 21, 2017 to September 21, 2018) Advance Payment Details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications How to Pay Fees to Health Products and Food Branch (HPFB) Background Register of Certificates of Supplementary Protection and Applications Certificates of Supplementary Protection and Applications - Human Use Certificate of Supplementary Protection (CSP) and/or Application Number Medicinal Ingredient(s) New Drug Submission (NDS) Number Patent Number Patent Expiry Dateyyyy-mm-dd Application Status CSP Term Beginsyyyy-mm-dd CSP Term Endsyyyy-mm-dd 900039 abemaciclib 215268 2747055 2029-12-15 Issued 2029-12-16 2031-12-15 900045 acalabrutinib 214504 2841886 2032-07-11 Issued 2032-07-12 2034-07-11 900056 alpelisib 226941 2734819 2029-09-08 Issued 2029-09-09 2031-09-08 900035 antihemophilic factor (recombinant, B-domain deleted, pegylated) (also known as damoctocog alfa pegol) 210935 2586379 2025-11-14 Issued 2025-11-15 2027-11-14 900027 apalutamide 211942 2875767 2033-06-04 Issued 2033-06-05 2033-07-04 900026 baricitinib 193687 2718271 2029-03-10 Issued 2029-03-11 2031-03-10 900012 benralizumab 204008 2685222 2028-05-14 Issued 2028-05-15 2030-05-14 900028 bictegravir sodium / emtricitabine / tenofovir alafenamide hemifumarate 203718 2416757 2021-07-20 Refused 900020 brigatinib 210369 2723961 2029-05-21 Issued 2029-05-22 2031-05-21 900015 brodalumab 195317 2663537 2027-10-01 Issued 2027-10-02 2029-10-01 900060 brolucizumab 226224 2727839 2029-06-25 Issued 2029-06-26 2031-06-25 900057 cabotegravir (cabotegravir sodium) 227315 2606282 2026-04-28 Issued 2026-04-29 2028-04-28 900063 cedazuridine / decitabine 234610 2702274 2028-10-16 Issued 2028-10-17 2030-10-16 900022 cenegermin 218145 2346257 2019-10-11 Refused 900011 coagulation factor IX (recombinant), pegylated 201114 2462930 2022-10-09 Refused 900052 coagulation factor IX (recombinant), pegylated 201114 2665480 2027-10-04 Refused 900019 crisaborole 206906 2597982 2026-02-16 Issued 2026-02-17 2028-02-16 900041 dacomitinib 214572 2565812 2025-04-25 Issued 2025-04-26 2027-04-25 900058 darolutamide 226146 2777896 2030-10-27 Issued 2030-10-28 2032-10-27 900017 darunavir ethanolate / cobicistat / emtricitabine / tenofovir alafenamide hemifumarate 199705 2678907 2028-02-22 Issued 2028-02-23 2030-02-22 900051 dolutegravir (dolutegravir sodium) / lamivudine 220275 3003988 2031-01-24 Issued 2031-01-25 2033-01-24 900021 dolutegravir (dolutegravir sodium) / rilpivirine (rilpivirine hydrochloride) 206402 2606282 2026-04-28 Refused 900034 doravirine 211293 2794377 2031-03-28 Issued 2031-03-29 2033-03-28 900004 dupilumab 201285 2737044 2029-10-27 Issued 2029-10-28 2031-10-27 900010 durvalumab 202953 2778714 2030-11-24 Issued 2030-11-25 2032-11-04 900024 emicizumab 212635 2817964 2031-11-17 Issued 2031-11-18 2033-08-03 900053 entrectinib 227517 2693901 2028-07-08 Issued 2028-07-09 2030-07-08 900074 eptinezumab 233288 2836649 2032-05-21 Pending 900070 erdafitinib 224529 2796204 2031-04-28 Issued 2031-04-29 2033-04-28 900025 erenumab 208607 2746858 2029-12-18 Issued 2029-12-19 2031-12-18 900018 ertugliflozin 204724 2733795 2029-08-17 Issued 2029-08-18 2031-08-17 900076 estetrol monohydrate / drospirenone 236197 2448278 2022-05-23 Pending 900033 fluticasone furoate, umeclidinium (as bromide), vilanterol (as trifenatate) 204880 2781487 2030-11-29 Issued 2030-11-30 2032-11-29 900044 galcanezumab 219521 2802102 2031-06-07 Issued 2031-06-08 2033-06-07 900055 gilteritinib fumarate 227918 2760061 2030-05-06 Issued 2030-05-07 2032-05-06 900062 glasdegib 225793 2690953 2028-06-16 Issued 2028-06-17 2030-06-16 900001 glecaprevir / pibrentasvir 202233 2807847 2031-10-12 Refused 900014 glycopyrronium (as bromide) / formoterol fumarate dihydrate 201306 2763936 2030-05-28 Refused 900003 guselkumab 200590 2635692 2026-12-28 Issued 2026-12-29 2028-12-28 900032 inotersen (inotersen sodium) 214274 2797792 2031-04-29 Issued 2031-04-30 2033-04-29 900023 insulin glargine / lixisenatide 207006 2740685 2029-10-09 Issued 2029-10-10 2031-10-09 900029 lanadelumab 213920 2786019 2031-01-06 Issued 2031-01-07 2033-01-06 900043 larotrectinib (larotrectinib sulfate) 219998 2741313 2029-10-21 Issued 2029-10-22 2031-10-21 900066 lefamulin (supplied as lefamulin acetate) 233292 2678795 2028-03-19 Issued 2028-03-20 2030-03-19 900069 lemborexant 231286 2811895 2031-09-20 Issued 2031-09-21 2033-09-20 900007 letermovir 204165 2524069 2024-04-17 Issued 2024-04-18 2026-04-17 900009 lifitegrast 199810 2609053 2026-05-17 Issued 2026-05-18 2028-05-17 900040 lorlatinib 215733 2863892 2033-02-20 Issued 2033-02-21 2034-02-23 900071 luspatercept 236441 2733911 2029-08-13 Issued 2029-08-14 2031-08-13 900002 neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily A / neisseria meningitidis grp B recombinant lipoprotein 2086 subfamily B 195550 2463476 2022-10-11 Issued 2022-10-12 2024-10-11 900008 olaratumab 203478 2680945 2026-06-19 Issued 2026-06-20 2028-06-19 900072 ozanimod (ozanimod hydrochloride) 232761 2723904 2029-05-14 Issued 2029-05-15 2031-05-14 900073 ozanimod (ozanimod hydrochloride) 232761 2780772 2030-11-15 Withdrawn 900067 polatuzumab vedotin 232303 2693255 2028-07-15 Issued 2028-07-16 2030-07-15 900050 prasterone 198822 2696127 2028-08-08 Withdrawn 900068 remdesivir 240551 2804840 2031-07-22 Issued 2031-07-23 2033-07-22 900016 ribociclib (ribociclib succinate) 203884 2734802 2029-08-20 Issued 2029-08-21 2031-08-20 900065 ripretinib 234688 2875970 2032-06-07 Issued 2032-06-08 2034-06-07 900042 risankizumab 215753 2816950 2031-11-02 Issued 2031-11-03 2033-11-02 900031 rivaroxaban 211611 2451258 2022-06-07 Pending 900046 romosozumab 197713 2607197 2026-04-28 Issued 2026-04-29 2028-04-28 900061 satralizumab 233642 2699834 2029-09-25 Issued 2029-09-26 2031-09-25 900005 semaglutide 202059 2601784 2026-03-20 Issued 2026-03-21 2028-03-20 900054 siponimod 223225 2747437 2029-12-16 Withdrawn 900059 siponimod 223225 2747992 2029-12-21 Issued 2029-12-22 2031-12-21 900038 suvorexant 160233 2670892 2027-11-30 Refused 900048 talazoparib (talazoparib tosylate) 220584 2732797 2029-07-27 Issued 2029-07-28 2031-07-27 900036 tezacaftor / Ivacaftor 211292 2742821 2028-11-12 Issued 2028-11-13 2030-11-12 900030 tisagenlecleucel 213547 2820681 2031-12-09 Issued 2031-12-10 2033-12-09 900064 tucatinib 235295 2632194 2026-11-15 Issued 2026-11-16 2028-11-15 900049 upadacitinib 223734 2781891 2030-12-01 Issued 2030-12-02 2032-12-01 900006 varicella-zoster kamagra glycoprotein E (gE) 200244 2600905 2026-03-01 Refused 900075 zanubrutinib 242748 2902686 2034-04-22 Pending Certificates of Supplementary Protection and Applications - Veterinary Use Certificate of Supplementary Protection (CSP) and/orApplication Number Medicinal Ingredient(s) New Drug Submission (NDS) Number Patent Number Patent Expiry Dateyyyy-mm-dd Application Status CSP Term Beginsyyyy-mm-dd CSP Term Endsyyyy-mm-dd 900013 lotilaner 193712 2747354 2029-12-17 Issued 2029-12-18 2031-12-17 900047 sarolaner/moxidectin/pyrantel (as pyrantel pamoate) 210868 2882200 2033-09-04 Issued 2033-09-05 2034-09-27 900037 sarolaner / selamectin 190913 2828397 2032-02-23 Issued 2032-02-24 2033-11-07 BackgroundThe Register of Certificates of Supplementary Protection (CSP) and Applications is maintained pursuant to the Certificate of Supplementary Protection Regulations and the Patent Act. The register includes information from CSPs and CSP applications. Under the subsection 115(1) of the Patent Act, the issuance of a CSP grants the certificate's holder and their legal representatives the same legal rights, privileges and liberties that are granted by the patent set out in the certificate, but only with respect to the making, constructing, using and selling of any drug that contains the medicinal ingredient, or combination of medicinal ingredients.The format of the register is an electronic table. The register lists, in alphabetical order, the medicinal ingredient(s) in the CSPs and CSP applications.Information regarding the patent set out in the CSP or CSP application is available at the Canadian Intellectual Property Office.For comments or questions, or to obtain a copy of a CSP or CSP application details, please contact the Office of Patented Medicines and Liaison by email at hc.opml-bmbl.sc@canada.ca or by telephone at 613-941-7281..

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MDEL Bulletin, December 03, 2021, from the Medical Devices Compliance ProgramOn this page About the cancellationIn December 2021, Health Canada will cancel medical device establishment licences (MDELs) Cipro for sale online for licence holders who have outstanding fees for kamagra uk safe their 2021 annual licence review (ALR) application. You do not need to take any action if you have sent your payment for your 2021 ALR application.The Fees in Respect of Drugs and Medical Devices Order (Fees Order) states that the ALR fee must be paid for Health Canada to review an application. The authority to withdraw or withhold services in case kamagra uk safe of non-payment is outlined in the MDEL bulletin Cancellation of MDELs for failure to pay fees. We posted this bulletin on June 24, 2021.If your establishment licence is cancelled, you are no longer authorized to conduct licensable activities (such as manufacturing, distributing or importing medical devices).

You must stop these activities as soon as you receive your cancellation letter.What cancellation means for licence fees Health Canada charges fees to examine a licence application. Normally, this fee is charged prior kamagra uk safe to our review of completed applications. If payment is not received, the application is not reviewed. However, to help meet the demand for medical devices during the erectile dysfunction treatment kamagra, we kamagra uk safe did review MDEL applications before collecting fees.

As a result, some establishments have had their MDEL application or annual licence review processed and still have an outstanding invoice that has not been paid.Failure to pay an outstanding invoice will result in the cancellation of your MDEL. If payment is not received, we will send the unpaid invoice to collections.If you’re unable to pay the MDEL fees for your 2021 ALR application in full due to financial reasons, please communicate directly with accounts receivable at ar-cr@hc-sc.gc.ca. You will be able to discuss the kamagra uk safe possibility of setting up a payment plan to pay these fees in instalments.Resuming activities after MDEL cancellation If your licence is cancelled and you wish to resume licensable activities, you must. Re-apply for a new establishment licence and pay the MDEL fee in advanceTo find out how to re-apply for a MDEL, please refer to our Guidance on medical device establishment licensing (GUI-0016).If your new licence is issued before April 1, 2022, you will also need to submit an ALR package before April 1, 2022, and pay the applicable fees to renew this licence.

This is in accordance with section 46.1(1) of the MDR.Contact us If you have questions about a MDEL or the application process, please contact the Medical Device Establishment Licensing Unit at mdel.questions.leim@hc-sc.gc.ca.If you have kamagra uk safe questions about invoicing and fees for an MDEL application, please contact the Cost Recovery Invoicing Unit at criu-ufrc@hc-sc.gc.ca.Related linksOctober 27, 2021 The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML). Artificial intelligence and machine learning technologies have the potential to kamagra uk safe transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day.

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Strong partnerships with our international public health partners will be crucial if we are to empower stakeholders to advance responsible innovations in this area. Thus, we expect this initial collaborative kamagra uk safe work can inform our broader international engagements, including with the IMDRF. We welcome your continued feedback through the public docket (FDA-2019-N-1185) at Regulations.gov, and we look forward to engaging with you on these efforts. The Digital Health Center of Excellence is kamagra uk safe spearheading this work for the FDA.

Contact us directly at Digitalhealth@fda.hhs.gov, software@mhra.gov.uk, and mddpolicy-politiquesdim@hc-sc.gc.ca. Guiding principles Multi-Disciplinary Expertise Is Leveraged Throughout the Total Product Life Cycle. In-depth understanding of a model's intended integration into clinical workflow, and the desired benefits and associated patient risks, can help ensure that ML-enabled medical devices are safe and effective and address clinically meaningful needs kamagra uk safe over the lifecycle of the device. Good Software Engineering and Security Practices Are Implemented.

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Users are also made aware of device modifications and updates from real-world performance monitoring, the basis for decision-making when available, and a means to communicate product concerns to the developer. Deployed Models Are kamagra uk safe Monitored for Performance and Re-training Risks Are Managed. Deployed models have the capability to be monitored in "real world" use with a focus on maintained or improved safety and performance. Additionally, when models are periodically or continually trained after deployment, there are appropriate controls in place to manage risks of overfitting, unintended bias, or degradation of the model (for example, dataset drift) that may impact the safety and performance of the model as it is used by the Human-AI team..

MDEL Bulletin, December 03, 2021, from the Medical Devices Compliance ProgramOn this buy kamagra online no prescription page About the cancellationIn December 2021, http://jsjohnsonphotography.com/cipro-for-sale-online/ Health Canada will cancel medical device establishment licences (MDELs) for licence holders who have outstanding fees for their 2021 annual licence review (ALR) application. You do not need to take any action if you have sent your payment for your 2021 ALR application.The Fees in Respect of Drugs and Medical Devices Order (Fees Order) states that the ALR fee must be paid for Health Canada to review an application. The authority to withdraw or withhold services in case of buy kamagra online no prescription non-payment is outlined in the MDEL bulletin Cancellation of MDELs for failure to pay fees.

We posted this bulletin on June 24, 2021.If your establishment licence is cancelled, you are no longer authorized to conduct licensable activities (such as manufacturing, distributing or importing medical devices). You must stop these activities as soon as you receive your cancellation letter.What cancellation means for licence fees Health Canada charges fees to examine a licence application. Normally, this fee is charged prior to our review buy kamagra online no prescription of completed applications.

If payment is not received, the application is not reviewed. However, to help meet the buy kamagra online no prescription demand for medical devices during the erectile dysfunction treatment kamagra, we did review MDEL applications before collecting fees. As a result, some establishments have had their MDEL application or annual licence review processed and still have an outstanding invoice that has not been paid.Failure to pay an outstanding invoice will result in the cancellation of your MDEL.

If payment is not received, we will send the unpaid invoice to collections.If you’re unable to pay the MDEL fees for your 2021 ALR application in full due to financial reasons, please communicate directly with accounts receivable at ar-cr@hc-sc.gc.ca. You will be able to discuss the possibility of setting up a payment plan to pay these fees in instalments.Resuming activities after MDEL cancellation If your licence is cancelled and you wish to resume licensable buy kamagra online no prescription activities, you must. Re-apply for a new establishment licence and pay the MDEL fee in advanceTo find out how to re-apply for a MDEL, please refer to our Guidance on medical device establishment licensing (GUI-0016).If your new licence is issued before April 1, 2022, you will also need to submit an ALR package before April 1, 2022, and pay the applicable fees to renew this licence.

This is in accordance with section 46.1(1) of the buy kamagra online no prescription MDR.Contact us If you have questions about a MDEL or the application process, please contact the Medical Device Establishment Licensing Unit at mdel.questions.leim@hc-sc.gc.ca.If you have questions about invoicing and fees for an MDEL application, please contact the Cost Recovery Invoicing Unit at criu-ufrc@hc-sc.gc.ca.Related linksOctober 27, 2021 The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).

Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new buy kamagra online no prescription and important insights from the vast amount of data generated during the delivery of health care every day. They use software algorithms to learn from real-world use and in some situations may use this information to improve the product's performance. But they also present unique considerations due to buy kamagra online no prescription their complexity and the iterative and data-driven nature of their development.

These 10 guiding principles are intended to lay the foundation for developing Good Machine Learning Practice that addresses the unique nature of these products. They will also help cultivate future growth in this rapidly progressing field. The 10 guiding principles identify areas where the International Medical Device Regulators Forum (IMDRF), international standards organizations and other collaborative bodies could buy kamagra online no prescription work to advance GMLP.

Areas of collaboration include research, creating educational tools and resources, international harmonization, and consensus standards, which may help inform regulatory policies and regulatory guidelines. We envision these guiding principles may buy kamagra online no prescription be used to. Adopt good practices that have been proven in other sectors Tailor practices from other sectors so they are applicable to medical technology and the health care sector Create new practices specific for medical technology and the health care sector As the AI/ML medical device field evolves, so too must GMLP best practice and consensus standards.

Strong partnerships with our international public health partners will be crucial if we are to empower stakeholders to advance responsible innovations in this area. Thus, we buy kamagra online no prescription expect this initial collaborative work can inform our broader international engagements, including with the IMDRF. We welcome your continued feedback through the public docket (FDA-2019-N-1185) at Regulations.gov, and we look forward to engaging with you on these efforts.

The Digital Health Center of Excellence is spearheading this work for the FDA buy kamagra online no prescription. Contact us directly at Digitalhealth@fda.hhs.gov, software@mhra.gov.uk, and mddpolicy-politiquesdim@hc-sc.gc.ca. Guiding principles Multi-Disciplinary Expertise Is Leveraged Throughout the Total Product Life Cycle.

In-depth understanding of a model's intended integration into clinical workflow, and the desired benefits and associated patient risks, can help ensure that ML-enabled medical devices are safe and effective and address clinically meaningful needs over the lifecycle of the device buy kamagra online no prescription. Good Software Engineering and Security Practices Are Implemented. Model design is implemented with attention to the "fundamentals" buy kamagra online no prescription.

Good software engineering practices, data quality assurance, data management, and robust cybersecurity practices. These practices include methodical risk management and design process that can appropriately capture and communicate design, implementation, and risk management decisions and rationale, as well as ensure data authenticity and integrity. Clinical Study Participants and Data Sets buy kamagra online no prescription Are Representative of the Intended Patient Population.

Data collection protocols should ensure that the relevant characteristics of the intended patient population (for example, in terms of age, gender, sex, race, and ethnicity), use, and measurement inputs are sufficiently represented in a sample of adequate size in the clinical study and training and test datasets, so that results can be reasonably generalized to the population of interest. This is important to manage any buy kamagra online no prescription bias, promote appropriate and generalizable performance across the intended patient population, assess usability, and identify circumstances where the model may underperform. Training Data Sets Are Independent of Test Sets.

Training and test datasets are selected and maintained to be appropriately independent of one another. All potential sources of dependence, including patient, data acquisition, and buy kamagra online no prescription site factors, are considered and addressed to assure independence. Selected Reference Datasets Are Based Upon Best Available Methods.

Accepted, best available methods for developing a reference dataset (that is, a reference standard) buy kamagra online no prescription ensure that clinically relevant and well characterized data are collected and the limitations of the reference are understood. If available, accepted reference datasets in model development and testing that promote and demonstrate model robustness and generalizability across the intended patient population are used. Model Design Is Tailored to the Available Data and Reflects the Intended Use of the Device.

Model design is suited to the available data and supports the active mitigation of known risks, like overfitting, performance degradation, and security buy kamagra online no prescription risks. The clinical benefits and risks related to the product are well understood, used to derive clinically meaningful performance goals for testing, and support that the product can safely and effectively achieve its intended use. Considerations include the impact of both global and local performance and buy kamagra online no prescription uncertainty/variability in the device inputs, outputs, intended patient populations, and clinical use conditions.

Focus Is Placed on the Performance of the Human-AI Team. Where the model has a "human in the loop," human factors considerations and the human interpretability of the model outputs are addressed with emphasis on the performance of the Human-AI team, rather than just the performance of the model in isolation. Testing Demonstrates Device Performance During Clinically Relevant buy kamagra online no prescription Conditions.

Statistically sound test plans are developed and executed to generate clinically relevant device performance information independently of the training data set. Considerations include the intended patient buy kamagra online no prescription population, important subgroups, clinical environment and use by the Human-AI team, measurement inputs, and potential confounding factors. Users Are Provided Clear, Essential Information.

Users are provided ready access to clear, contextually relevant information that is appropriate for the intended audience (such as health care providers or patients) including. The product's intended use and indications for use, performance of the buy kamagra online no prescription model for appropriate subgroups, characteristics of the data used to train and test the model, acceptable inputs, known limitations, user interface interpretation, and clinical workflow integration of the model. Users are also made aware of device modifications and updates from real-world performance monitoring, the basis for decision-making when available, and a means to communicate product concerns to the developer.

Deployed Models Are Monitored for Performance and Re-training Risks buy kamagra online no prescription Are Managed. Deployed models have the capability to be monitored in "real world" use with a focus on maintained or improved safety and performance. Additionally, when models are periodically or continually trained after deployment, there are appropriate controls in place to manage risks of overfitting, unintended bias, or degradation of the model (for example, dataset drift) that may impact the safety and performance of the model as it is used by the Human-AI team..

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Start Preamble Food and Drug Administration, Health and Human buy kamagra jelly australia Services how much does kamagra cost per pill (HHS). Notice. Renewal of advisory committee how much does kamagra cost per pill. The Food and Drug Administration (FDA) is announcing the renewal of the National Mammography Quality Assurance Advisory Committee by the Commissioner of Food and Drugs (the Commissioner).

The Commissioner has determined that it is in the public interest to renew the National Mammography Quality Assurance Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect how much does kamagra cost per pill until July 7, 2023, expiration date. Authority for the National Mammography Quality Assurance Advisory Committee will expire on July 7, 2023, unless the Commissioner formally determines that renewal is in the public interest. Start Further Info Aden Asefa, Office of Management, Center for Devices and Radiological Health, Food and Drug how much does kamagra cost per pill Administration, 10903 New Hampshire Ave., Bldg.

66, Rm. 5214, Silver Spring, MD 20993-0002, 301-796-0400, email. Aden.asefa@fda.hhs.gov. End Further Info End Preamble Start Supplemental Information Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the National Mammography Quality Assurance Advisory Committee (the Committee).

The committee is a non-discretionary Federal advisory committee established to provide advice to the Commissioner. The Commissioner is charged with the administration of the Federal Food, Drug and Cosmetic Act and various provisions of the Public Health Service Act. The Mammography Quality Standards Act of 1992 amends the Public Health Service Act to establish national uniform quality and safety standards for mammography facilities. The National Mammography Quality Assurance Advisory Committee advises the Secretary and, by delegation, the Commissioner or designee in discharging their responsibilities with Start Printed Page 49538respect to establishing a mammography facilities certification program.

The Committee shall advise the HHS Secretary and the Commissioner or designee on. (A) Developing appropriate quality standards and regulations for mammography facilities. (B) Developing appropriate standards and regulations for bodies accrediting mammography facilities under this program. (C) Developing regulations with respect to sanctions.

(D) Developing procedures for monitoring compliance with standards. (E) Establishing a mechanism to investigate consumer complaints. (F) Reporting new developments concerning breast imaging which should be considered in the oversight of mammography facilities. (G) Determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas.

(H) Determining whether there will exist a sufficient number of medical physicists after October 1, 1999. And (I) Determining the costs and benefits of compliance with these requirements. The Committee shall consist of a core of 15 members, including the Chair. Members and the Chair are selected by the Commissioner or designee from among physicians, practitioners, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography.

Members will be invited to serve for overlapping terms of up to 4 years. Almost all members of this committee serve as Special Government Employees. The core of voting members shall include at least four individuals from among national breast cancer or consumer health organizations with expertise in mammography, and at least two practicing physicians who provide mammography services. In addition to the voting members, the Committee shall include two nonvoting industry representative members who have expertise in mammography equipment.

The Committee may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests. Further information regarding the most recent charter and other information can be found at https://www.fda.gov/​AdvisoryCommittees/​CommitteesMeetingMaterials/​Radiation-EmittingProducts/​NationalMammographyQualityAssuranceAdvisoryCommittee/​ucm520365.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This notice is issued under the Federal Advisory Committee Act (5 U.S.C.

App.). For general information related to FDA advisory committees, please visit us at https://www.fda.gov/​AdvisoryCommittees/​default.htm. Start Signature Dated. August 31, 2021.

Lauren K. Roth, Acting Principal Associate Commissioner for Policy. End Signature End Supplemental Information [FR Doc. 2021-19108 Filed 9-2-21.

8:45 am]BILLING CODE 4164-01-PStart Preamble Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. Notice. As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that two meetings are scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meetings will be open to the public via WebEx and teleconference.

A pre-registered public comment session will be held during both meetings. Pre-registration is required for members of the public who wish to attend the meetings via WebEx/teleconference. Individuals who wish to send in their written public comment should send an email to CARB@hhs.gov. Registration information is available on the website http://www.hhs.gov/​paccarb and must be completed by October 1, 2021 for the October 6, 2021 virtual Public Meeting.

And, by November 29, 2021 for the November 30-December 1, 2021 virtual Public Meeting. Additional information about registering for the meeting and providing public comment can be obtained at http://www.hhs.gov/​paccarb on the Upcoming Meetings page. The October meeting is scheduled to be held on October 6, 2021, from 10:00 a.m. To 11:00 a.m.

ET (times are tentative http://dentysta-zamosc.com.pl/oferta/ and subject to change). The November/December meeting is scheduled to be held on November 30, 2021 from 10:00 a.m. To 3:00 p.m. And December 1, 2021, from 10:00 a.m.

To 3:00 p.m. ET (times are tentative and subject to change). The confirmed times and agenda items for both meetings will be posted on the website for the PACCARB at http://www.hhs.gov/​paccarb when this information becomes available. Pre-registration for attending the meeting is strongly suggested and should be completed no later than October 1, 2021 for the October meeting and November 29, 2021 for the November/December meeting.

Instructions regarding attending this meeting virtually will be posted at least one week prior to the meeting at. Http://www.hhs.gov/​paccarb. Start Further Info Jomana Musmar, M.S., Ph.D., Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, Room L616, Switzer Building, 330 C St.

SW, Washington, DC 20024. Phone. 202-746-1512. Email.

CARB@hhs.gov. End Further Info End Preamble Start Supplemental Information The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB), established by Executive Order 13676, is continued by Section 505 of Public Law 116-22, the kamagra and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA). Activities and duties of the Advisory Council are governed by the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees.

The PACCARB shall advise and provide information and recommendations to the Secretary regarding programs and policies intended to reduce or combat antibiotic-resistant bacteria that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance. The PACCARB shall function solely for advisory purposes. Such advice, information, and recommendations may be related to improving. The effectiveness of antibiotics.

Research and advanced research on, and the development of, improved and innovative methods for combating or reducing antibiotic resistance, including new treatments, rapid point-of-care diagnostics, alternatives to antibiotics, including alternatives to animal antibiotics, and antimicrobial stewardship activities. Surveillance of antibiotic-resistant bacterial s, including publicly available and up-to-date information on resistance to antibiotics. Education for health care providers and the public with respect to up-to-date information on antibiotic resistance and ways to reduce or combat such resistance to antibiotics related to humans and animals. Methods to prevent or reduce the transmission of antibiotic-resistant bacterial s.

Including stewardship programs. And coordination with respect to international efforts in order to inform and advance the United States capabilities to combat antibiotic resistance. The October 6, 2021 public meeting will be held virtually and is dedicated to deliberation and vote of the letter with recommendations from the Immediate Action Subcommittee of the Advisory Council. The meeting agenda will be posted on the PACCARB website at http://www.hhs.gov/​paccarb when it has been finalized.

All agenda items are tentative and subject to change. The November 31, 2021 and December 1, 2021 public meeting will be held virtually and will be dedicated to addressing the current situation regarding antimicrobial resistance as well as to a presentation from the National Academies of Sciences, Engineering, and Medicine on their report, Examining the Long-term Health and Economic Effects of Antimicrobial Resistance in the United States. The meeting agenda will be posted on the PACCARB website at http://www.hhs.gov/​paccarb when it has been finalized. All agenda items are tentative and subject to change.

Instructions regarding attending both meetings virtually will be posted one Start Printed Page 49552week prior to each meeting at. Http://www.hhs.gov/​paccarb. Members of the public will have the opportunity to provide comments live during the October meeting via conference line by pre-registering online at http://www.hhs.gov/​paccarb. Pre-registration is required for participation in this session with limited spots available.

Written public comments can also be emailed to CARB@hhs.gov by midnight October 1, 2021 and should be limited to no more than one page. All public comments received prior to October 1, 2021, will be provided to Advisory Council members. Members of the public will have the opportunity to provide comments live during the November 30, 2021 and December 1, 2021 public meeting via conference line by pre-registering online at http://www.hhs.gov/​paccarb. There will be two separate sessions available for public comment.

An Innovation Spotlight will be held on November 30, 2021 where companies and/or organizations involved in combating antibiotic resistance have an opportunity to present their work to members of the Advisory Council. And on December 1, 2021, where all members of the general public are welcome to provide oral comment during this separate session. Pre-registration is required for participation in these sessions with limited spots available. Further information about these two sessions can be found online at http://www.hhs.gov/​paccarb.

Written public comments can also be emailed to CARB@hhs.gov by midnight November 29, 2021 and should be limited to no more than one page. All public comments received prior to November 29, 2021, will be provided to Advisory Council members. Start Signature Dated. August 26, 2021.

Jomana F. Musmar, Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Office of the Assistant Secretary for Health. End Signature End Supplemental Information [FR Doc. 2021-19027 Filed 9-2-21.

Start Preamble kamagra for sale Food and Drug Administration, Health and Human Services buy kamagra online no prescription (HHS). Notice. Renewal of buy kamagra online no prescription advisory committee.

The Food and Drug Administration (FDA) is announcing the renewal of the National Mammography Quality Assurance Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the National Mammography Quality Assurance Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until buy kamagra online no prescription July 7, 2023, expiration date.

Authority for the National Mammography Quality Assurance Advisory Committee will expire on July 7, 2023, unless the Commissioner formally determines that renewal is in the public interest. Start Further Info Aden Asefa, Office of Management, Center for Devices and Radiological Health, Food buy kamagra online no prescription and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.

5214, Silver Spring, MD 20993-0002, 301-796-0400, email. Aden.asefa@fda.hhs.gov. End Further Info End Preamble Start Supplemental Information Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the National Mammography Quality Assurance Advisory Committee (the Committee).

The committee is a non-discretionary Federal advisory committee established to provide advice to the Commissioner. The Commissioner is charged with the administration of the Federal Food, Drug and Cosmetic Act and various provisions of the Public Health Service Act. The Mammography Quality Standards Act of 1992 amends the Public Health Service Act to establish national uniform quality and safety standards for mammography facilities.

The National Mammography Quality Assurance Advisory Committee advises the Secretary and, by delegation, the Commissioner or designee in discharging their responsibilities with Start Printed Page 49538respect to establishing a mammography facilities certification program. The Committee shall advise the HHS Secretary and the Commissioner or designee on. (A) Developing appropriate quality standards and regulations for mammography facilities.

(B) Developing appropriate standards and regulations for bodies accrediting mammography facilities under this program. (C) Developing regulations with respect to sanctions. (D) Developing procedures for monitoring compliance with standards.

(E) Establishing a mechanism to investigate consumer complaints. (F) Reporting new developments concerning breast imaging which should be considered in the oversight of mammography facilities. (G) Determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas.

(H) Determining whether there will exist a sufficient number of medical physicists after October 1, 1999. And (I) Determining the costs and benefits of compliance with these requirements. The Committee shall consist of a core of 15 members, including the Chair.

Members and the Chair are selected by the Commissioner or designee from among physicians, practitioners, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography. Members will be invited to serve for overlapping terms of up to 4 years. Almost all members of this committee serve as Special Government Employees.

The core of voting members shall include at least four individuals from among national breast cancer or consumer health organizations with expertise in mammography, and at least two practicing physicians who provide mammography services. In addition to the voting members, the Committee shall include two nonvoting industry representative members who have expertise in mammography equipment. The Committee may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests.

Further information regarding the most recent charter and other information can be found at https://www.fda.gov/​AdvisoryCommittees/​CommitteesMeetingMaterials/​Radiation-EmittingProducts/​NationalMammographyQualityAssuranceAdvisoryCommittee/​ucm520365.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This notice is issued under the Federal Advisory Committee Act (5 U.S.C.

App.). For general information related to FDA advisory committees, please visit us at https://www.fda.gov/​AdvisoryCommittees/​default.htm. Start Signature Dated.

August 31, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy.

End Signature End Supplemental Information [FR Doc. 2021-19108 Filed 9-2-21. 8:45 am]BILLING CODE 4164-01-PStart Preamble Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

Notice. As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that two meetings are scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meetings will be open to the public via WebEx and teleconference.

A pre-registered public comment session will be held during both meetings. Pre-registration is required for members of the public who wish to attend the meetings via WebEx/teleconference. Individuals who wish to send in their written public comment should send an email to CARB@hhs.gov.

Registration information is available on the website http://www.hhs.gov/​paccarb and must be completed by October 1, 2021 for the October 6, 2021 virtual Public Meeting. And, by November 29, 2021 for the November 30-December 1, 2021 virtual Public Meeting. Additional information about registering for the meeting and providing public comment can be obtained at http://www.hhs.gov/​paccarb on the Upcoming Meetings page.

The October meeting is scheduled to be held on October 6, 2021, from 10:00 a.m. To 11:00 a.m. ET (times http://www.em-erables-horbourg-wihr.site.ac-strasbourg.fr/classe1/?p=12132 are tentative and subject to change).

The November/December meeting is scheduled to be held on November 30, 2021 from 10:00 a.m. To 3:00 p.m. And December 1, 2021, from 10:00 a.m.

To 3:00 p.m. ET (times are tentative and subject to change). The confirmed times and agenda items for both meetings will be posted on the website for the PACCARB at http://www.hhs.gov/​paccarb when this information becomes available.

Pre-registration for attending the meeting is strongly suggested and should be completed no later than October 1, 2021 for the October meeting and November 29, 2021 for the November/December meeting. Instructions regarding attending this meeting virtually will be posted at least one week prior to the meeting at. Http://www.hhs.gov/​paccarb.

Start Further Info Jomana Musmar, M.S., Ph.D., Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Office of the Assistant Secretary for Health, U.S. Department of Health and Human Services, Room L616, Switzer Building, 330 C St. SW, Washington, DC 20024.

CARB@hhs.gov. End Further Info End Preamble Start Supplemental Information The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB), established by Executive Order 13676, is continued by Section 505 of Public Law 116-22, the kamagra and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA). Activities and duties of the Advisory Council are governed by the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C.

App.), which sets forth standards for the formation and use of federal advisory committees. The PACCARB shall advise and provide information and recommendations to the Secretary regarding programs and policies intended to reduce or combat antibiotic-resistant bacteria that may present a public health threat and improve capabilities to prevent, diagnose, mitigate, or treat such resistance. The PACCARB shall function solely for advisory purposes.

Such advice, information, and recommendations may be related to improving. The effectiveness of antibiotics. Research and advanced research on, and the development of, improved and innovative methods for combating or reducing antibiotic resistance, including new treatments, rapid point-of-care diagnostics, alternatives to antibiotics, including alternatives to animal antibiotics, and antimicrobial stewardship activities.

Surveillance of antibiotic-resistant bacterial s, including publicly available and up-to-date information on resistance to antibiotics. Education for health care providers and the public with respect to up-to-date information on antibiotic resistance and ways to reduce or combat such resistance to antibiotics related to humans and animals. Methods to prevent or reduce the transmission of antibiotic-resistant bacterial s.

Including stewardship programs. And coordination with respect to international efforts in order to inform and advance the United States capabilities to combat antibiotic resistance. The October 6, 2021 public meeting will be held virtually and is dedicated to deliberation and vote of the letter with recommendations from the Immediate Action Subcommittee of the Advisory Council.

The meeting agenda will be posted on the PACCARB website at http://www.hhs.gov/​paccarb when it has been finalized. All agenda items are tentative and subject to change. The November 31, 2021 and December 1, 2021 public meeting will be held virtually and will be dedicated to addressing the current situation regarding antimicrobial resistance as well as to a presentation from the National Academies of Sciences, Engineering, and Medicine on their report, Examining the Long-term Health and Economic Effects of Antimicrobial Resistance in the United States.

The meeting agenda will be posted on the PACCARB website at http://www.hhs.gov/​paccarb when it has been finalized. All agenda items are tentative and subject to change. Instructions regarding attending both meetings virtually will be posted one Start Printed Page 49552week prior to each meeting at.

Http://www.hhs.gov/​paccarb. Members of the public will have the opportunity to provide comments live during the October meeting via conference line by pre-registering online at http://www.hhs.gov/​paccarb. Pre-registration is required for participation in this session with limited spots available.

Written public comments can also be emailed to CARB@hhs.gov by midnight October 1, 2021 and should be limited to no more than one page. All public comments received prior to October 1, 2021, will be provided to Advisory Council members. Members of the public will have the opportunity to provide comments live during the November 30, 2021 and December 1, 2021 public meeting via conference line by pre-registering online at http://www.hhs.gov/​paccarb.

There will be two separate sessions available for public comment. An Innovation Spotlight will be held on November 30, 2021 where companies and/or organizations involved in combating antibiotic resistance have an opportunity to present their work to members of the Advisory Council. And on December 1, 2021, where all members of the general public are welcome to provide oral comment during this separate session.

Pre-registration is required for participation in these sessions with limited spots available. Further information about these two sessions can be found online at http://www.hhs.gov/​paccarb. Written public comments can also be emailed to CARB@hhs.gov by midnight November 29, 2021 and should be limited to no more than one page.

All public comments received prior to November 29, 2021, will be provided to Advisory Council members. Start Signature Dated. August 26, 2021.

Jomana F. Musmar, Designated Federal Officer, Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, Office of the Assistant Secretary for Health. End Signature End Supplemental Information [FR Doc.

2021-19027 Filed 9-2-21. 8:45 am]BILLING CODE 4150-44-P.