Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA posted the final guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. This guidance is intended to provide a forward-thinking approach to promote the development of safe and effective AI-enabled devices. Additionally, this guidance provides recommendations on the information to include in a predetermined change control plan (PCCP) in a marketing submission for a device that includes one or more AI-enabled device software functions (AI-DSFs). On January 14, 2025, the FDA will host a webinar for industry and others interested in learning more about the final guidance.
- On Monday, the FDA issued draft guidance outlining the requirements and procedures that infant formula manufacturers should follow to notify the FDA of a permanent discontinuance or an interruption of the manufacture of infant formula that is likely to lead to a meaningful disruption in the supply of such infant formula in the United States. This guidance is one of the steps the FDA is taking to improve the resiliency of the infant formula supply and to ensure that consumers have the utmost confidence that infant formula available in the U.S. is safe and nutritious.
- On Monday, the FDA issued the 2024 edition of the Voluntary National Retail Food Regulatory Program Standards, which defines the key elements of an effective retail food regulatory program for state, local, tribal, and territorial food regulatory agencies. The Retail Program Standards include recommendations for designing and managing retail food initiatives, as well as recognizing programs that show progress in implementing the standards. They provide a foundation and system upon which all regulatory retail food programs can build through a continuous improvement process.
- On Monday, the FDA updated the outbreak advisory for Salmonella Typhimurium infections linked to cucumbers. As of November 26, 2024, a total of 68 people infected with the outbreak strain of Salmonella have been reported from 19 states. Of the 50 people for whom information is available, 18 have been hospitalized. No deaths have been reported. Of the 33 people interviewed, 27 (82%) reported eating cucumbers. On November 27, 2024, SunFed Produce, LLC initiated a voluntary recall of all sizes of American/slicer cucumbers that were grown by Agrotato, S.A. de C.V. in Sonora, Mexico. On November 29, 2024, Baloian Farms of Arizona Co., Inc. initiated a voluntary recall of all sizes of American/slicer cucumbers that were grown by Agrotato, S.A. de C.V. On December 1, 2024, Russ Davis Wholesale initiated a voluntary recall of American/slicer cucumbers and multiple products containing recalled cucumbers. The FDA is working with the recalling firms and their direct customers to determine if additional downstream customer recalls are necessary. The FDA’s investigation is ongoing.
- On Monday, the Office of Global Policy and Strategy published its latest From a Global Perspective: Reflections on the 19th International Conference of Drug Regulatory Authorities, a blog by Kimberlee Trzeciak, FDA Deputy Commissioner for Policy, Legislation, and International Affairs.
“A rising tide that lifts all boats can help ensure a secure, resilient, and high-quality medical product supply chain, benefiting patients in the United States and worldwide,” she said.
- On Tuesday, the FDA published a Spotlight on CDER Science featuring a collaboration between the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research and outside researchers to conduct a study to explore if adding a concise summary of risk information would more succinctly communicate drug safety information to healthcare providers (HCPs), and, in combination with the Lactation subsection narrative included in prescribing information (PI), support HCP clinical decision-making for lactating patients. This research advances CDER’s efforts to understand how HCPs interpret the Lactation subsection of the PI and how the PI can be improved to better communicate information to HCPs about the safety of prescription drugs used during lactation.
- On Friday, the FDA issued final guidance, “Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development.” This guidance is intended to help sponsors planning to use circulating cell-free plasma derived tumor DNA (ctDNA) as a biomarker in cancer clinical trials conducted under an investigational new drug application (IND) and/or to support marketing approval of drugs and biological products for treating solid tumor malignancies in the early-stage (curative-intent) setting.
- On Wednesday, November 27, the FDA issued draft guidance, “Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products.” This draft guidance provides recommendations to sponsors regarding the measurement of ovarian toxicity using clinical measures and biomarkers of ovarian function in relevant cancer clinical trials that enroll premenopausal adults with ovaries.
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