![]() Today, FDA provided additional guidance to help prescribers evaluate potential drug interactions when using Paxlovid therapy for COVID-19. This action is the result of increased domestic manufacturing of N95 respirators, as well as updates to the FDA’s supply chain assessment based on engagement with industry and federal stakeholders, and the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health’s (NIOSH) approval of new disposable N95s and reusable respirators. Califf, M.D., Commissioner of Food and Drugs.įDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply Today, the FDA published the FDA Voices: “ FDA’s Overdose Prevention Framework Aims to Prevent Drug Overdoses and Reduce Death,” by Robert M. The FDA amended the emergency use authorizations (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. On Thursday, the FDA published the FDA Voices: “Using A Whole-Of-Governments Approach to Combating Illicit Health Products,” by Cathy Hermsen, Assistant Commissioner for Criminal Investigations and Ritu Nalubola, Director of the FDA’s Europe Office.įDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose Today, the FDA published the 2022: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report, which outlines topics the agency has identified as needing continued targeted investment in regulatory science research. ![]() Today, the FDA posted FAQs on Testing for Monkeypox with answers to frequently asked questions relating to the development and performance of tests for monkeypox.
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