January 10, 2025 - FDA Roundup: January 10, 2025

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

• Today the FDA released a Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. The strategy builds on the Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula MarketExternal Link Disclaimerthat was released in early 2023 in direct response to the February 2022 infant formula recall and the subsequent shortage of infant formula in the U.S. The FDA also partnered with the National Academies of Sciences, Engineering and Medicine, as directed by Congress, to further study challenges in the infant formula market in the U.SExternal Link Disclaimer. in order to inform a long-term strategy. The long-term strategy focuses on our long-term goal of achieving a more robust and nimble U.S. infant formula supply and identifies actions we have taken since 2023.
  
  "Consumers deserve to have the utmost confidence that infant formula available in the U.S. is safe and nutritious," said Jim Jones, FDA Deputy Commissioner for Human Foods. "We are proud of the actions we have taken to protect the integrity of the infant formula supply chain. We also recognize that additional efforts are needed and are committed to continued stakeholder engagement and increased oversight of the U.S. infant formula market."
• On Wednesday, the FDA published the FDA Voices, "CDER Brings Many Safe and Effective Therapies to Patients and Consumers in 2024," by Patrizia Cavazzoni, M.D., Director, Center for Drug Research and Evaluation (CDER). This FDA Voices covers highlights from the 2024 New Drug Therapy Approvals report, also published on Wednesday. The report features drug approvals that CDER considers likely to have a significant impact on public health. The 2024 report includes approvals for therapies that collectively treat a wide range of conditions, including a first-in-class drug for schizophrenia, three novel antibiotics and new drugs for many types of cancer.
• On Wednesday, the FDA released a Request For Comments (RFC) soliciting public input on new opportunities and emergent monitoring needs for possible inclusion in the forthcoming National Antimicrobial Resistance Monitoring System (NARMS) 2026-2030 Strategic Plan. The Federal Register notice about the RFC includes instructions for submitting comments, as well as specific questions and requests for information meant to prompt helpful submissions. The agency will be accepting public comments through March 26, 2025.
• On Wednesday, the FDA published the Create and Keep a Medication List for Your Health Consumer Update. Many people of all ages take medications. Keeping track of when, how and why you use medications is important for your health and safety. A medication list is a tool to help you keep track of all the prescription medications, OTC drugs, vitamins and supplements that you take. Keeping a medication list helps health care professionals know about your current health and minimize medication errors and adverse drug interactions. It can be a lifesaving tool, especially during an emergency.
• On Wednesday, the FDA updated the outbreak advisory for Salmonella Typhimurium infections linked to cucumbers. Epidemiologic and traceback information demonstrated that American/slicer cucumbers grown by Agrotato, S.A. de C.V. in Sonora, Mexico were the source of illnesses in this outbreak. Several companies issued recalls for American/slicer cucumbers and products containing recalled cucumbers during the investigation. CDC has now declared the outbreak over, and the FDA's investigation is closed.

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