FDA Roundup: December 3, 2024
SILVER SPRING, Md., Dec. 3, 2024 — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
The FDA has posted the final guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. This guidance aims to promote the development of safe and effective AI-enabled devices. It also includes recommendations on the information to incorporate into a predetermined change control plan (PCCP) in a marketing submission for devices featuring one or more AI-enabled device software functions (AI-DSFs). A webinar for industry and interested parties will be hosted by the FDA on January 14, 2025, to further discuss the final guidance.
On Monday, the FDA issued draft guidance specifying the requirements and procedures that infant formula manufacturers should follow to notify the FDA about a permanent discontinuance or an interruption of manufacturing infant formula likely to cause a significant supply disruption in the United States. This guidance is a step towards improving the resiliency of the infant formula supply and ensuring consumer confidence regarding the safety and nutritional value of infant formula available in the U.S.
Also on Monday, the FDA released the 2024 edition of the Voluntary National Retail Food Regulatory Program Standards. This document defines key elements for an effective retail food regulatory program applicable to state, local, tribal, and territorial food regulatory agencies. The Retail Program Standards offer recommendations for designing and managing retail food initiatives, and recognize programs demonstrating progress in implementing these standards. They serve as a foundation for continuous improvement in retail food regulatory programs.
The FDA updated its outbreak advisory for Salmonella Typhimurium infections linked to cucumbers on Monday. As of November 26, 2024, there have been 68 reported cases across 19 states with people infected by the outbreak strain of Salmonella. From the 50 individuals with available information, 18 were hospitalized, and no deaths have been reported. Among 33 interviewed, 27 (82%) stated they had consumed cucumbers. On November 27, 2024, SunFed Produce, LLC recalled all sizes of American/slicer cucumbers grown by Agrotato, S.A. de C.V. in Sonora, Mexico. Following that, Baloian Farms of Arizona Co., Inc. initiated a voluntary recall of American/slicer cucumbers on November 29, 2024. Moreover, on December 1, 2024, Russ Davis Wholesale recalled cucumbers and products containing recalled cucumbers. The FDA continues to work with the recalling firms and their customers to assess if further downstream recalls are necessary, with the investigation ongoing.
On Monday, the Office of Global Policy and Strategy released its latest insights titled “From a Global Perspective: Reflections on the 19th International Conference of Drug Regulatory Authorities.” The Deputy Commissioner for Policy, Legislation, and International Affairs highlighted the importance of a secure, resilient, and high-quality medical product supply chain, which can benefit patients both in the U.S. and worldwide.
On Tuesday, the FDA featured a Spotlight on CDER Science, showcasing a collaboration between the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research. This joint effort aims to explore whether a concise summary of risk information can improve the communication of drug safety information to healthcare providers (HCPs). This research is intended to enhance the clarity of the Lactation subsection in prescribing information (PI) to better support HCP clinical decision-making for lactating patients.
On Friday, the FDA issued final guidance on the “Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development.” This guidance is meant to assist sponsors intending to use circulating cell-free plasma derived tumor DNA (ctDNA) as a biomarker in clinical trials for cancer under investigational new drug applications (INDs) and to aid in the marketing approval process for drugs and biological products targeting solid tumor malignancies in the early-stage setting.
The FDA also released draft guidance on November 27 concerning the “Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products.” This draft specifies recommendations for sponsors on measuring ovarian toxicity through clinical measures and biomarkers of ovarian function in relevant cancer trials that involve premenopausal adults.
The FDA’s mission is to safeguard public health by ensuring the safety and effectiveness of human and veterinary drugs, vaccines, biological products, and medical devices. It also oversees the safety of the nation’s food supply, cosmetics, dietary supplements, and tobacco products.
