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Monkeypox response updates
FDA takes significant action to expand access to testing
FDA announced steps to further increase monkeypox testing capacity and accessibility nationwide as part of its continued commitment to addressing the ongoing outbreak.
“Since the beginning of the monkeypox outbreak, the agency has used the full breadth of its authorities to work quickly and proactively to ensure the availability of medical countermeasures, including diagnostics, to prevent the spread of the disease,” said FDA Commissioner Robert M. Califf, M.D. “We will continue to engage federal public health partners like the Centers for Disease Control and Prevention, laboratories, commercial manufacturers, health care professionals, and consumers to facilitate the availability of monkeypox tests to people and communities who need them.” (September 7, 2022)
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Just a Minute! videos
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COVID-19 vaccine updates
ICYMI: Bivalent boosters
On August 31, 2022, FDA amended the EUAs of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.
Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233 (TTY 1-888-720-7489) to find COVID-19 vaccines and boosters near you in the U.S.
Related Just a Minute! videos:
Novavax COVID-19 vaccine update
FDA reissued the August 19, 2022, letter of authorization (PDF) for Novavax COVID-19 Vaccine, Adjuvanted to revise the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Novavax, Inc. to include myocarditis and pericarditis.
Because some cases of myocarditis or pericarditis following vaccine administration may not meet the definition of serious adverse events, this change will help ensure that cases of myocarditis and pericarditis are reported by Novavax, Inc. and vaccination providers to VAERS. The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (PDF) has also been revised to include information about this updated reporting requirement. (September 12, 2022)
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 Are you ready for emergencies?
September is National Preparedness Month. Planning for hurricane season and other potential disasters can be stressful. Learn what you can do now to be ready.
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Emergency Use Authorization (EUA) updates
Monkeypox testing guidance & EUA templates
FDA issued guidance (Policy for Monkeypox Tests to Address the Public Health Emergency) that outlines the agency’s current thinking regarding enforcement policies, recommendations for EUA requests for monkeypox diagnostic tests, and the FDA’s plans to prioritize review of EUA requests.
The agency is also providing voluntary templates that test developers may use when validating a test or when submitting an EUA request. In addition to the guidance, FDA issued the first EUA for a monkeypox in vitro diagnostic, and published a new page: Monkeypox Emergency Use Authorizations for Medical Devices.
Also see the new FDA page, Monkeypox and Medical Devices, which includes information about previously cleared monkeypox tests. (September 7, 2022)
In vitro diagnostic (test) EUAs
As of September 13, 2022, 438 tests and sample collection devices are authorized by FDA under EUAs. These include 301 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1,111 revisions to test EUAs. Also see: COVID-19 Test Basics
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Events
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New! September 14, 2022: Webinar on the Policy for Monkeypox Tests (12:05 p.m. - 1:00 p.m. ET) - FDA will host a webinar about the recently published final guidance, Policy for Monkeypox Tests to Address the Public Health Emergency. During this webinar the FDA will provide highlights of the final guidance and answer questions from webinar attendees.
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New! September 14, 2022: U.S. Senate Committee on Health, Education, Labor & Pensions hearing: Stopping the Spread of Monkeypox: Examining the Federal Response (10:00 a.m. ET) - FDA Commissioner Dr. Robert Califf will testify.
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September 14, 2022: An Overview of Sentinel’s Publicly Available Analytics Tools webinar (12:00 p.m. ET) - This webinar will explore the resources available in Sentinel for individuals unfamiliar with Sentinel’s analytics tools and the Sentinel Common Data Model. Please register in advance.
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September 19, 2022: FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs (virtual) - The workshop will focus on comparative clinical studies associated with biosimilar development programs and will discuss possible innovative ideas that have the potential to streamline and improve the efficiency of biosimilar development. Advance registration required.
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September 20-22, 2022: 2022 Center for Biologics Evaluation and Research (CBER) Science Symposium (12:00 - 4:00 p.m. ET, virtual) - To discuss scientific topics related to the regulation of biologics and highlight science conducted at CBER by showcasing how scientific research informs regulatory decision making, and to provide a forum for developing collaborations within FDA and with external organizations. Advance registration required.
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September 21-22, 2022: 2022 Public Meeting of the National Antimicrobial Resistance Monitoring System (NARMS) (virtual) - FDA, in cooperation with the U.S. Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, its partners in the National Antimicrobial Resistance Monitoring System (NARMS), opened registration for the 2022 Public Meeting of NARMS. The meeting is open to all stakeholders at no cost.
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September 27, 2022: FDA Drug Topics: Development and U.S. Regulation of Preventative Vaccines (webinar, 1:00 - 2:15 p.m. ET) - To provide an overview of the development and federal regulations for vaccines in the United States, including key statutes that grant FDA authority to regulate vaccines, precipitating historical events, and current regulatory requirements for vaccine licensure and marketing approval.
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October 5, 2022: Study Data Standards Update for CBER: Your Guide to a Successful Submission (webcast, 1:00 - 2:00 p.m. ET) - CBER will discuss CBER’s support and requirement starting March 15, 2023 for the Standard for the Exchange of Nonclinical Data (SEND), which was published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog.
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October 6, 2022: Vaccines and Related Biological Products Advisory Committee meeting (virtual, 8:30 a.m. - 12:40 p.m. ET) - The committee will meet in open session to discuss strain selection for influenza virus vaccines for the 2023 Southern Hemisphere influenza season.
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October 11, 2022: FDA NanoDay Symposium 2022 (webinar) - To address drug development of products that contain nanomaterials in their formulation and how the guidance to industry for products that contain nanomaterials finalized in April 2022 can be implemented in filings to the FDA. Discussion will include case studies on the development of the COVID mRNA lipid nanoparticle vaccine products.
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October 20, 2022: COVID-19 Evidence Accelerator: What We've Learned, Where We're Headed (webinar, 1:00 p.m. ET) - A public meeting hosted by the Reagan-Udall Foundation for the FDA and Friends of Cancer Research, to highlight accomplishments and share learnings, including how best to leverage real-world data and improve data interoperability, to address current and future health challenges.
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Information for industry and health care providers
Monkeypox virus diagnostics opportunity from NIH
The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative established the Independent Test Assessment Program (ITAP) to accelerate regulatory review and availability of high-quality, accurate, and reliable over-the-counter COVID-19 tests to the public. ITAP is accepting new proposals on a rolling basis to address the diagnostic needs of the monkeypox outbreak. ITAP support will help accelerate the validation, regulatory authorization, and commercialization of point-of-care (POC) and home monkeypox virus tests. Proposals for POC and home tests that can directly detect the monkeypox virus and kits for at-home monkeypox virus self-collection are being accepted as of September 7, 2022.
Recently posted FDA guidance documents
Also see EUA section above for new monkeypox testing guidance
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.
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In case you missed it
Focus Areas of Regulatory Science
In September, FDA published the 2022 Focus Areas of Regulatory Science (FARS) report. Updates on FDA research include public health emergency preparedness and response, increasing choice and competition, unleashing the power of data, and much more.
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Resources to keep yourself and others safe from COVID-19
Find out where to get a COVID-19 vaccine, test, or treatment in your community at COVID.gov. Call 1-800-232-0233 (TTY 1-888-720-7489) with questions. (Also available in Spanish and Simplified Chinese.)
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 350 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
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FDA Medical Countermeasures Initiative (MCMi) News)
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