FDA Roundup: November 3, 2023

FDA News Release

• For Immediate Release: November 03, 2023

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 announced that its Center for Devices and Radiological Health (CDRH) is seeking input from the public on advancing health equity and facilitating access to digital health technologies for detecting prediabetes and type 2 diabetes, particularly in racial and ethnic minorities. CDRH is uniquely positioned to advance the development of high-quality, safe, and effective technologies to meet the needs of all patients and consumers, including diverse populations. 
• On Thursday, the FDA proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. This action is part of our regulatory authority over ingredients added to food, which includes reassessing previously evaluated food ingredients and addressing safety concerns. Brominated vegetable oil (BVO) is a vegetable oil that is modified with bromine. As authorized, it is used in small amounts to keep the citrus flavoring from floating to the top in some beverages. The FDA is issuing a proposed rule now because the agency has recent data from studies it conducted that demonstrate adverse health effects in animals at levels more closely approximating real-world human exposure. Based on these data and remaining unresolved safety questions, the FDA can no longer conclude that the use of BVO in food is safe.
• On Thursday, the FDA issued a guidance, which is being implemented immediately, titled: Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions. The guidance provides recommendations for limited modifications affecting the safety or effectiveness of a device approved through the FDA’s PMA or HDE program, where the modification is necessary to address current manufacturing limitations, potential shortages, or supply chain issues.
• On Wednesday, the FDA revised the EUA for Paxlovid to facilitate the transition from the U.S. government’s distribution of Paxlovid labeled for use under the EUA to Pfizer’s distribution of the commercial (NDA-labeled) Paxlovid. The FDA has updated the frequently asked questions about Paxlovid during this transition period and encourages people to visit the HHS Paxlovid landing page for additional information.
• On Wednesday, the FDA released a CDER From Our Perspective summarizing a recently published article in Open Exploration titled, “A U.S. FDA Perspective on Cannabis Research and Drug Development.” In the article, the FDA presents a breakdown of cannabis and cannabis-derived product (CCDP) applications the agency has received over the past 50 years, summarizes our experiences and challenges in reviewing CCDP research applications, and provides recommendations and resources for those interested in studying CCDPs in human clinical trials. For more information, please visit FDA’s 50 Years of Experience with Cannabis Research Helping to Support Tomorrow’s Cannabis Drug Development. 
• On Tuesday, the FDA approved pembrolizumab (Keytruda, Merck) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC). View full prescribing information for Keytruda.
• On Tuesday, the FDA issued a Safety Alert advising restaurants and food retailers not to sell and to dispose of oysters and consumers not to eat oysters from Fanny Bay Oysters based in British Columbia, Canada harvested on 10/17/2023 from harvest area 14-8 Landfile #278757 and shipped to distributors in California and Washington due to Vibrio parahaemolyticus test results.