FDA Roundup: December 13, 2024

SILVER SPRING, Md., Dec. 13, 2024 /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's Center for Drug Evaluation and Research (CDER) announced the new CDER Center for Real-World Evidence Innovation (CCRI) which aims to coordinate, advance, and promote the use of real-world data (RWD) and real-world evidence (RWE) in regulatory decision-making across CDER. For more information as it becomes available, visit the CCRI webpage.
  
  
• On Thursday, MedPage Today published an article authored by FDA Commissioner, Dr. Robert Califf and CDER's deputy center director for Substance Use and Behavioral Health, Dr. Marta Sokolowska. The op-ed discusses the FDA's recently launched Prescribe with Confidence campaign, which aims to inform, encourage and provide resources to prescribers on utilizing medication to treat opioid use disorder.
  
  
• On Thursday, the FDA issued a letter to retailers and distributors of cookware products to inform them that certain imported cookware products made from aluminum, brass, and aluminum alloys known as Hindalium/Hindolium or Indalium/Indolium, demonstrate the potential to leach lead into food and that this cookware should not be distributed or sold in the U.S. market.
  
  
• On Wednesday, the FDA issued updated guidance entitled Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. In summary, the guidance finalizes the frequently asked questions and answers (FAQ) in Appendix B (Q1-19). In addition, the guidance includes three new FAQ in Appendix B (Q20-22) for comment purposes before they are finalized. Submit comments by January 13, 2025.
  
  
• On February 5, 2025, the FDA's Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee will hold a joint public meeting. The committees will discuss the findings of prospective and retrospective epidemiological studies examining the risks and predictors of misuse, abuse, addiction, and fatal and non-fatal opioid overdose in patients with long-term use of opioid analgesics. The docket will be open for public review and comment until February 4, 2025.

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