FDA Roundup: August 2, 2024

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

• Today, the FDA published the FDA Voices: “Advancing Clinical Trial Participation for the LGBTQIA+ Community,” by Christine Lee, Acting Associate Commissioner for Minority Health, Office of Minority Health and Health Equity. Representatives of the FDA were fortunate to attend a community discussion on advancing clinical trial diversity for sexual and gender minority communities to help improve the generalizability of trial results across the entire population of patients who may use medical products. In collaboration with the North Carolina Community Health Center Association and the Association of Clinical Research Professionals-Research Triangle Park Chapter in North Carolina, the roundtable included members of the REACH Consortium, researchers, patients, community members, and LGBTQIA+ health professionals and advocates.
• On Thursday, the FDA approved Jemperli (dostarlimab-gxly) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adult patients with primary advanced or recurrent endometrial cancer (EC). Dostarlimab-gxly previously was approved with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent EC that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).
• On Thursday, the FDA announced the roster of the Digital Health Advisory Committee that will advise the FDA on issues related to digital health technologies (DHTs), providing relevant expertise and perspective to enhance the agency’s understanding of the benefits, risks, and clinical outcomes associated with the use of DHTs. Additionally, on November 20-21, 2024, the FDA plans to hold the inaugural Digital Health Advisory Committee meeting in person in Gaithersburg, MD, with simultaneous webcast. Topics planned to be addressed include how the use of Generative AI may impact safety and effectiveness of medical devices enabled with this technology. Further details about this meeting will be announced in the Federal Register in accordance with the FDA’s policies and procedures for Advisory Committee Meetings.
• On Thursday, the FDA introduced online resources to provide information about reprocessing single-use medical devices for health care facilities and FAQs. The FDA remains dedicated to providing resources to help health care facilities establish, implement, or improve their quality assurance programs related to reprocessing single-use medical devices.
• On Thursday, the FDA announced executive career opportunities related to its reorganization to create a unified Human Foods Program. The FDA anticipates making more announcements as the agency continues to work toward the reorganized Human Foods Program. The reorganization will allow the agency to more effectively realize the vision laid out in the FDA’s Food Safety Modernization Act, elevate the importance of nutrition to help reduce diet-related diseases, modernize and strengthen oversight of food chemical safety, strengthen state partnerships, and embrace innovative food and agricultural technologies that will position the agency to more effectively regulate and uphold safety of the nation’s food supply.

Related Information

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.