FDA Roundup: March 14, 2025

SILVER SPRING, Md., March 14, 2025 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Thursday, the FDA posted information on the flu vaccine composition for the 2025-2026 U.S. flu season. The agency, in consultation with our federal partners, reviewed the available data and made its recommendations to manufacturers of the U.S.-licensed influenza vaccines for the production of updated vaccines for the 2025-2026 flu season. Based on this timing, the agency does not anticipate any impact on vaccine supply or timing of availability.
  
  
• On Thursday, the FDA's Center for Drug Evaluation and Research (CDER) published two case studies and a case study user guide, developed as part of the Accelerating Rare disease Cures (ARC) Program's Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. These case studies provide examples of approaches successfully used by sponsors when designing and conducting rare disease drug development programs. The ARC Program launched LEADER 3D to better understand and address the unique challenges in bringing rare disease products to market. As part of the initiative, CDER's Rare Diseases Team worked with an independent contractor to conduct interviews with the rare disease drug development community and performed a review of public docket comments to identify educational opportunities across regulatory topics of interest in rare disease drug development. These case studies and the other materials on the LEADER 3D website are reflective of the needs and priorities heard from our valuable partners in the rare disease drug development community. Read the case studies at the LEADER 3D website.
  
  
• On Wednesday, the FDA announced that the American Society of Addiction Medicine (ASAM) has issued the final guideline, "The Joint Clinical Practice Guideline on Benzodiazepine Tapering: Considerations When Benzodiazepine Risks Outweigh Benefits". This guideline focuses on evidence-informed and consensus-based strategies to help clinicians determine whether tapering benzodiazepine medications may be appropriate for a given patient, and if so, how to taper them. The FDA awarded a grant to ASAM in 2022 to develop this guideline, which will serve as a standard of care for safe tapering of benzodiazepines. The draft guideline issued in June 2024.
  
  
• On Tuesday, the FDA issued a Safety Alert advising restaurants and retailers not to serve or sell and consumers not to eat certain frozen half-shell oysters from Republic of Korea designated area II, potentially contaminated with norovirus.

Additional Resources: 

• FDA Newsroom 

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration