Coronavirus Disease 2019 (COVID-19) updates | Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last 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. |  Upcoming 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.
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 225 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) | |  | Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter. Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity "Creating a world where health equity is a reality for all." www.fda.gov/healthequity  |
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