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Today, the FDA’s Office of Global Policy and Strategy published “ How a European Data Law is Impacting FDA,” which looks at how the European Union’s General Data Protection Regulation may be impacting the FDA’s public health activities. Today, the FDA posted a safety communication to provide information to blood establishments regarding monkeypox virus and blood donations.

The agency also warned the public about certain spray sunscreens that have been recalled because of benzene contamination and launched a new external webpage to highlight the Operation Lascar Initiative. Today, the FDA issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans.

Outlines much of the broad range of work the FDA is undertaking to combat the COVID-19 pandemic and prepare for future emergencies. Report: FDA's Work to Combat the COVID-19 Pandemic Today, the FDA authorized the emergency use of Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age. Additionally, on October 11, the FDA and the Duke-Margolis Center for Health Policy will hold a virtual public workshop titled, “ Challenges and Opportunities for REMS Integration, Innovation, and Modernization.” Today, the FDA’s Office of Global Policy and Strategy posted an article about the FDA’s fruitful partnership with the Inter-American Institute for Cooperation in Agriculture.

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Prescribers should review each patient’s full list of medications and use other resources to evaluate for potential drug interactions in patients who take medications that are not included on the Fact Sheet or checklist at this time. 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.

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