Coronavirus Disease 2019 (COVID-19) updates  Updates from FDA in our ongoing response to the COVID-19 pandemic since our last email update include: - June 28, 2022: FDA Roundup including authorization of an extension to the shelf-life of the refrigerated AstraZeneca monoclonal antibody, Evusheld, which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. Consumers concerned about COVID-19 should consult with their health care provider.
- June 28, 2022: GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down
- June 28, 2022: Shelf-Life Extension of Evusheld under Emergency Use Authorization
- June 27, 2022: 2021 Office of New Drugs Annual Report (PDF), including efforts during the second year of the COVID-19 pandemic, specifically related to trial designs for COVID-19 therapies, collaboration with drug sponsors, and issuance of guidances addressing the impact of emergent variants on drug development.
- June 27, 2022: FDA Authorizes Shelf-Life Extension for REGEN-COV From 24 months to 30 Months
- June 24, 2022: FDA Roundup including announcement of an upcoming public meeting to discuss pulse oximeter accuracy and limitations
Bookmark www.fda.gov/coronavirus for the latest. | COVID-19 vaccine updates COVID-19 testing update At-home COVID-19 test information and FAQs now available in Spanish Medical countermeasure update HHS expanding monkeypox testing capacity to five commercial laboratory companies Last week, the Department of Health and Human Services (HHS), through the Centers for Disease Control and Prevention (CDC), began shipping FDA-cleared orthopoxvirus tests to five commercial laboratory companies, including some of the nation's largest reference laboratories, to quickly increase monkeypox testing capacity and access in every community during the ongoing monkeypox outbreak. Since the United States detected its first case, FDA has worked with commercial laboratories and manufacturers to make monkeypox testing more readily available to patients and providers who need tests. FDA is working closely with CDC to increase production of its FDA-cleared test. FDA has cleared CDC's test for distribution beyond the current Laboratory Response Network and has also cleared the use of additional reagents and automation to increase the testing capacity of laboratories using the CDC test. CDC has also published the testing protocol (PDF) from their FDA-cleared orthopoxvirus test for any interested laboratory to use to begin testing for monkeypox. FDA is currently exercising enforcement discretion with respect to laboratory developed tests (LDTs), such as those developed by hospitals or academic laboratories. (June 28, 2022) Advanced manufacturing update An FDA self-audit of continuous manufacturing for drug products Continuous manufacturing (CM) technology has the potential to improve product quality and reliability, lower manufacturing costs, reduce waste, decrease inventory, and increase manufacturing flexibility and agility in response to product demand. Alternatively, is it possible that CM can also increase time to regulatory approval and market entry, hinder submission of post-approval changes, and raise inspectional scrutiny? CDER's Office of Pharmaceutical Quality (OPQ) set out to find answers by conducting a self-audit of approved U.S. regulatory submissions that employ CM vs. traditional batch processes, and analyzing regulatory outcomes during the product lifecycle and at approval. (June 28, 2022) More about advanced manufacturing at FDA  Events - June 29, 2022: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:05 - 1:00 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host additional events in this series on July 27 and August 24, 2022.
- July 11-13, 2022: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - This course, presented by FDA and the University of Texas Medical Branch, will be held at the National Training, Simulation and Quarantine Center (TSQC) at University of Nebraska Medical Center/Nebraska Medicine, a National Ebola Training and Education Center (NETEC) facility. Registration is now open for in-person and virtual attendance. Last chance to register! Pre-registration is requested by June 30, 2022.
- July 14, 2022: FDA Grand Rounds: One Health at FDA: From Concept to Application, 12:00 - 1:00 p.m. ET, presented by CAPT Brianna Skinner, DVM, MPH, DACLAM, of FDA's Office of Counterterrorism and Emerging Threats (OCET) and Annamaria Castiglia, DVM, of FDA's Center for Veterinary Medicine (CVM).
- New! August 11, 2022: 2022 FDA CVM Advanced Manufacturing Public Meeting, 1:00 - 4:00 p.m. EDT - CVM will host a virtual public meeting on the FDA's oversight of advanced manufacturing technologies for animal drugs. The meeting will be a listening session to provide stakeholders with an opportunity to share information and insight on this topic with CVM. Learn more: FDA Announces Virtual Public Meeting on Advanced Manufacturing for Animal Drugs
In case you missed it 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.) | |  | List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 280 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. | |  | 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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