FDA Roundup: October 4, 2024

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

• On Monday, Oct. 7, the Science Board to the FDA will convene to receive an update from the New Alternative Methods subcommittee and hear details about the FDA's reorganization, implemented on Oct. 1, and includes significant updates to the Office of the Chief Scientist and the creation of a unified Human Foods Program. This meeting is open to the public and prior registration is not required. Attendees can access the meeting here.
• On Thursday, the FDA Office of Women’s Health (OWH) released its updated Women’s Health Research Roadmap. The Roadmap, provides a science-based framework to address women’s health research questions and to build women’s health science into the FDA’s research activities and outlines priority areas in which new or further research is needed and serves as a catalyst for research collaborations both internal and external to the FDA. 

  “The updated roadmap serves as a guide to drive research that will address the health needs of women and bridge knowledge gaps to improve health outcomes.,” said Kaveeta Vasisht, M.D., Pharm.D., FDA’s Associate Commissioner for Women’s Health and Director, Office of Women’s Health. 

  The Roadmap will be used by OWH as a tool to promote women’s health research, advance strategic and diverse research investments, and maximize research impact.

• On Thursday, the FDA posted a new video in the “FDA In Your Day” series. In this video Chief Medical Officer, Dr. Hilary Marston, discusses the importance of making a game plan for fall respiratory virus season. 
• On Thursday, the FDA approved Opdivo (nivolumab) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Adverse reactions were similar to those occurring in other clinical trials of nivolumab with chemotherapy. Of those who received neoadjuvant nivolumab, 5.3% were unable to undergo surgery due to adverse reactions compared with 3.5% in the placebo arm. In addition, 4.5% who received neoadjuvant treatment and surgery in the nivolumab arm had delays in surgery due to adverse reactions compared with 3.9% in the placebo arm. See the prescribing information for additional safety information. Full prescribing information for Opdivo will be posted on Drugs@FDA.
• On Thursday, the FDA updated the outbreak advisory, Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies to include additional cases.
• On Thursday, the FDA published a list of unsafe imported radiation-emitting products for consumers. The FDA has significant concerns about potentially hazardous radiation-emitting electronic products that importers try to bring into the U.S. To help protect public health, the FDA publishes “Import Alerts” along with information about unsafe radiation-emitting products. Each alert lists the reason for the alert, what products or manufacturers are affected, what FDA laws and/or regulations appear to have been violated, and other information. The FDA also publishes a list of known radiation-emitting electronic products that have failed safety testing and are hazardous to use. However, this is not an exhaustive list. Consumers should be aware that even electronic products — that are not on the alerts list — may be hazardous if used unsafely. When using radiation-emitting electronic products, consumers should follow safety instructions.
• On Tuesday, the FDA announced a new, streamlined approach for processing complaints, including whistleblower complaints related to FDA-regulated products. The public will be able to direct complaints about foods and dietary supplements to the Human Foods Program through online reporting forms, and by phone to 1-888-SAFEFOOD. 
• On Tuesday, the FDA’s Center for Devices and Radiological Health (CDRH) announced that breakthrough designated devices reviewed in the Office of Radiological Health and the Division of Ophthalmic Devices are eligible to enroll in the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. Additionally, CDRH provided a resource for innovators and collaborators: TAP Pilot Engagement Tips that is intended to provide considerations that may help foster productive engagement between medical device sponsors and non-FDA parties including patients, payers, and health care providers during the medical device design and development process.
• Last week, the FDA approved its 60th biosimilar since the start of the biosimilars program. The FDA celebrates the successful growth of the program and its impact on expanded treatment options for patients.

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