| 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: - February 23, 2021: COVID-19 Update including guidances for medical product developers to address the emergence and potential future emergence of variants of SARS-CoV-2
- February 22, 2021: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
- February 19, 2021: COVID-19 Update including a warning letter for selling an unapproved product with fraudulent COVID-19 claims.
- February 19, 2021: FDA warns about limitations and accuracy of pulse oximeters - Also see the updated Consumer Update, Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy
- February 18, 2021: USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging
- February 16, 2021: FDA Voices - Reflections on a Record Year for Novel Device Innovation Despite COVID-19 Challenges
- February 16, 2021: COVID-19 Update including a warning letter for selling unapproved products, including unapproved products with fraudulent COVID-19 claims
- February 12, 2021: COVID-19 Update including an EUA for a monoclonal antibody combination for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19; and a revised guidance, Investigational COVID-19 Convalescent Plasma
Bookmark www.fda.gov/coronavirus for the latest. | |  | | |  Health Equity and COVID-19: What Minority Communities Need to Know February 25, 2021, 6:00 - 7:00 p.m. ET Join the FDA's Office of Minority Health and Health Equity for a conversation about health equity and COVID-19 with Dr. Peter Marks, Director of the FDA Center for Biologics Evaluation and Research, and RADM Richardae Araojo, Associate Commissioner for Minority Health, and Director of the FDA Office of Minority Health and Health Equity. Learn about the latest COVID-19 updates, including information about vaccines and the FDA's approval process. COVID-19 vaccine updates COVID-19 vaccine safety surveillance FDA recently posted a new web page, COVID-19 Vaccine Safety Surveillance, which provides an overview of our active and passive systems used to monitor the safety of authorized COVID-19 vaccines. The FDA's Center for Biologics Evaluation and Research (CBER) is conducting these surveillance efforts in collaboration with the Centers for Disease Control and Prevention (CDC), the Center for Medicare and Medicaid Services (CMS), the Department of Veterans Affairs (VA), and other academic and large non-government healthcare data systems. Watch the VRBPAC meeting live On February 26, 2021, 9:00 a.m. - 5:30 p.m. ET, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss EUA of the Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older. Watch live on YouTube. USDA, FDA underscore current epidemiologic and scientific information indicating no transmission of COVID-19 through food or food packaging Statement from Acting USDA Secretary Kevin Shea and Acting FDA Commissioner Janet Woodcock, M.D. After more than a year since the COVID-19 outbreak was declared a global health emergency, the U.S. Department of Agriculture, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention continue to underscore that there is no credible evidence of food or food packaging associated with or as a likely source of viral transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19. | | Emergency Use Authorization (EUA) updates | Diagnostic test EUAs As of today, 331 tests and sample collection devices are authorized by FDA under EUAs. These include 247 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There are 37 molecular authorizations that can be used with home-collected samples. There is 1 molecular prescription at-home test, 1 antigen prescription at-home test, and 1 over-the-counter (OTC) at-home antigen test. Also see: Coronavirus Testing Basics | |  | | | Events - Today! February 24, 2020: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - During the virtual town hall for SARS-CoV-2 test developers, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event.
- New! February 25, 2021: Health Equity and Covid-19: What Minority Communities Need To Know webinar, 6:00 p.m. ET. Please register in advance.
- February 26, 2021: Vaccines and Related Biological Products Advisory Committee meeting (webcast) to discuss the EUA request for a COVID-19 vaccine from Janssen Biotech Inc.
- March 10, 2021: Precisely practicing medicine for COVID, from a half million tested patients and a trillion points of data (Zoom webcast), 3:00 - 4:00 p.m. ET - This Center of Excellence in Regulatory Science and Innovation (CERSI) lecture is presented by Atul Butte, MD, PhD, University of California, San Francisco (UCSF) -Stanford CERSI. Registration is not required.
- New! 365 Days and Counting: COVID-19's Impact on the Oncology Community Zoom webinar, 11:00 a.m. - 12:00 p.m. ET, hosted by the FDA Oncology Center of Excellence. Please register in advance.
- May 26-27, 2021: Save the date! 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual) - FDA scientific experts and nationally renowned scientists will discuss eight topic areas including one on medical countermeasures, infectious disease, and pathogen reduction technologies. This year's keynote speaker is NIAID Director Anthony Fauci, MD.
| | Information for industry FDA issues policies to guide medical product developers addressing virus variants Suite of guidances addresses vaccines, diagnostics and therapeutics - FDA issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19. The FDA has anticipated the possible emergence of SARS-CoV-2 variants and has already been prepared to address changes in the virus, informed by the agency's experience with evolving infectious diseases, such as influenza and HIV. While the FDA has already been communicating with individual medical product sponsors to provide information and scientific advice as they evaluate the impact of SARS-CoV-2 variants on their products, in the spirit of transparency and to continue to encourage public input on this important topic, the agency published this suite of guidances. (February 22, 2021) Guidance links: Letter to Health Care Providers on using ventilator splitters during the COVID-19 pandemic - This letter provides up-to-date information concerning multiplexing ventilator tubing connectors, also known as ventilator splitters, in situations in which no alternatives for invasive ventilatory support are available. The Letter to Health Care Providers also includes important information about ventilator splitters, including descriptions of features that may reduce certain risks associated with the use of ventilator splitters, considerations for health care providers and facilities when using ventilator splitters, and instructions for reporting problems with a device to the FDA. (February 9, 2021)
Recommendations for investigational COVID-19 convalescent plasma - FDA revised its guidance, Investigational COVID-19 Convalescent Plasma and associated web page, to reflect the reissued Emergency Use Authorization for COVID-19 convalescent plasma (PDF). Specifically, the guidance provides recommendations to blood establishments on the collection and labeling of high titer COVID-19 convalescent plasma under the EUA. In addition, the revisions address when individuals who have received an investigational COVID-19 monoclonal therapy as a participant in a clinical trial, or received an authorized or licensed COVID-19 monoclonal antibody therapy, qualify as convalescent plasma donors. (February 11, 2021)
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 70 COVID-19-related guidances to date. | | In case you missed it  COVID-19 vaccines FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Get the latest: www.fda.gov/covid19vaccines |  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. | Did someone forward you this email? Subscribe.
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