| Coronavirus Disease 2019 (COVID-19) updates  Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include: Bookmark www.fda.gov/coronavirus for the latest. | | | FDA approves drug to treat smallpox Disease considered eradicated in 1980, but drug development for smallpox is an important component for medical countermeasure response  On June 4, 2021, FDA approved Tembexa (brincidofovir) to treat smallpox. Although the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that the virus that causes smallpox, the variola virus, could be used as a bioweapon. Although naturally occurring smallpox no longer exists, concerns about potential uses of variola virus as a bioweapon has made smallpox drug development an important component of the U.S. medical countermeasures response. Tembexa was developed in conjunction with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA). FDA granted approval of Tembexa to Chimerix Inc. | Related links: A conversation with the FDA Chief Scientist  Learn about the Emergency Use Authorization (EUA) process In a new episode of FDA's Health Equity Forum podcast, Associate Commissioner for Minority Health RADM Richardae Araojo discusses FDA's EUA process with FDA Chief Scientist RADM Denise Hinton. "The EUA authority is a vital part of the FDA's efforts to protect the public health. Our scientists and medical experts use the most rigorous and strict guidelines to review an application. ... FDA has not sacrificed high standards for safety, accuracy, and effectiveness to authorize the use of vaccines or other medical products for COVID-19. And we have not, and will not, authorize the use of any COVID-19 product that does not meet the agency's high standards. And finally, I'd like to encourage the public to get vaccinated as soon as they are able." | Strengthening the U.S. pharmaceutical supply chain | Executive Order 14017 on America's Supply Chains Keeping the U.S. drug supply chain secure, robust, and resilient is essential for the health and national security, and economic prosperity of the United States during emergencies like the COVID-19 pandemic and for the provision of day-to-day health care. On February 24, 2021, President Biden signed Executive Order 14017 to secure America's critical supply chains. The Executive Order directed the Administration to launch an immediate 100-day review and strategy development process to identify and address vulnerabilities in the supply chains of four key product sectors, including pharmaceuticals. HHS led the development of a pharmaceutical supply chain report and its recommendations, which were published in a White House report (PDF) on June 8, 2021. | |  | | | Emergency Use Authorization (EUA) updates  FDA reissues REGEN-COV EUA On June 3, 2021, FDA reissued the Letter of Authorization for REGEN-COV (Casirivimab and Imdevimab) (PDF) treatment for COVID-19 to authorize: - A dosage change from 1200 mg of casirivimab and 1200 mg of imdevimab to 600 mg of casirivimab and 600 mg of imdevimab;
- A new coformulation product that contains 600 mg of casirivimab and 600 mg of imdevimab in a single vial; and
- Addition of subcutaneous (under-the-skin) injection as an alternative route of administration when intravenous (administered into a vein) infusion is not feasible and would lead to delay in treatment.
These updates are also included in the PDF Fact Sheet for Health Care Providers, the Fact Sheet for Patients, Parents, and Caregivers, , and the Frequently Asked Questions on the Emergency Use Authorization of REGEN-COV, and Dear Healthcare Provider Letter. FDA amends COVID-19 convalescent plasma EUA On June 2, 2021, FDA amended (PDF) the COVID-19 convalescent plasma EUA (PDF) to include the DiaSorin LIASON SARS-CoV-2 TrimericS IgG test as an acceptable test for use in the manufacture of high titer COVID-19 convalescent plasma. Diagnostic test EUAs As of June 8, 2021, 384 tests and sample collection devices are authorized by FDA under EUAs. These include 275 molecular tests and sample collection devices, 81 antibody and other immune response tests, and 28 antigen tests. There are 52 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 molecular prescription at-home test, 3 antigen prescription at-home tests, 5 antigen over-the-counter (OTC) at-home tests, and 2 molecular OTC at-home tests. FDA has authorized 11 antigen tests and 3 molecular tests for serial screening programs. The FDA has also authorized 529 revisions to EUA authorizations. Also see: Coronavirus Testing Basics | | |  Events - June 9, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - FDA will host additional webinars in this series on Wednesdays in June.
- June 9, 2021: Public workshop (virtual): Model Informed Drug Development Approaches for Immunogenicity Assessments - to discuss best practices and future directions of quantitative methods for predicting immunogenicity of biologic products - 8:00 a.m. - 5:00 p.m. ET - Register
- June 10, 2021: Vaccines and Related Biological Products Advisory Committee (webcast) - During this meeting, FDA will provide considerations on data to support licensure and Emergency Use Authorization for COVID-19 vaccines intended for use in individuals 12 through 17 years of age. The committee will also discuss in open session, in general, the data needed to support an authorization and/or licensure of a COVID-19 vaccine intended for use in pediatric populations. The committee will not discuss any specific products. Meeting materials are now available.
- June 14-18, 2021: Virtual Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories
- New! July 19-23, 2021: Regulatory Education for Industry (REdI) Annual Conference 2021 - Learn directly from the FDA's regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA's regulatory requirements. The keynote speaker, Acting Commissioner Janet Woodcock, MD, will reflect on FDA's use of EUAs and other resources in making drug, device, and biological products available to support the public health response to the COVID-19 pandemic.
| | Information for industry Update: SARS-CoV-2 viral mutations: Impact on COVID-19 tests - FDA posted an update to the SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page to add new information about a potential impact on the performance of the Mesa Biotech Inc. Accula SARS-CoV-2 Test due to a genetic mutation at positions 28877-28878 (AG to TC) in patient samples. (June 3, 2021)
FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain - On June 3, 2021, FDA published two guidance documents and made available two draft guidance documents to help ensure that prescription drugs are identified and traced properly as they move through the supply chain. Also see: Drug Supply Chain Security Act (DSCSA)
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. | | In case you missed it  Find a COVID-19 vaccine near you Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. Learn more at vaccines.gov. |  COVID-19 communication toolkits
Visit our communication toolkits page for materials and messages from the FDA about COVID-19 to communicate with patients, the public, and health care professionals. |  List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 250 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. |  Learn more about FDA's Medical Countermeasures Initiative This new report showcases FDA's work to prepare for all types of public health emergencies. This year's report includes a snapshot of FDA's COVID-19 response during the reporting period. (May 26, 2021) | Did someone forward you this email? Subscribe.
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