Latest FDA Update: December 3, 2024

Today, the U.S. Food and Drug Administration (FDA) offers a concise summary of recent updates from the agency:

• The FDA released final guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan regarding AI-Enabled Device Software Functions. This guidance aims to support the development of safe and effective AI-driven devices, outlining essential information for inclusion in a predetermined change control plan (PCCP) within a marketing submission. A webinar on this guidance will be conducted by the FDA on January 14, 2025.
• This Monday, the FDA shared draft guidance for infant formula manufacturers, detailing protocols for notifying the FDA about permanent manufacturing discontinuations or interruptions that could significantly disrupt supply in the U.S. This is part of the FDA’s efforts to enhance the resilience of the infant formula market and ensure the safety and nutritional quality of available products.
• On Monday as well, the FDA unveiled the 2024 Voluntary National Retail Food Regulatory Program Standards. This document outlines critical components for an effective retail food regulatory program to be adopted by relevant regulatory agencies, offering a groundwork for continuous improvement in food safety initiatives.
• The FDA also updated the outbreak advisory for Salmonella Typhimurium infections associated with cucumbers, reporting 68 cases across 19 states as of November 26, 2024. The FDA continues to collaborate with manufacturers on associated voluntary recalls by companies like SunFed Produce, LLC and Russ Davis Wholesale.
• On Monday, an update was published by the Office of Global Policy and Strategy regarding the 19th International Conference of Drug Regulatory Authorities, featuring insights from Kimberlee Trzeciak, FDA Deputy Commissioner.
• Furthermore, a recent Spotlight on CDER Science was released, presenting a study exploring whether succinct risk summaries would better convey drug safety to healthcare providers for lactating patients.
• On Friday, the FDA finalized guidance entitled Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development, aiming to assist sponsors in utilizing circulating tumor DNA as a biomarker in cancer clinical trials.
• Lastly, the FDA issued draft guidance on November 27 concerning the Assessment of Ovarian Toxicity in drug development for premenopausal adults with cancer, providing sponsors with recommendations on measurement protocols.

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