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. 

  “We are pleased to announce these science and policy leadership openings as an important step in augmenting our expertise to fully realize the Human Foods Program and further continue our public health mission” says Jim Jones, Deputy Commissioner for Human Foods.

• On Wednesday, the FDA issued warning letters to five online retailers for selling unauthorized disposable e-cigarette products marketed under the brand names Geek Bar, Lost Mary, and Bang. The retailers included Smoke and Vape Company, LLC d/b/a Smoke and Vape Co.; Smoking Vibes LLC d/b/a Smoking Vibes; Cavalry Industries d/b/a Select Vape; HTXW LLC d/b/a FOMO Culture; and Global Supply Allies Inc. d/b/a Vapor Grab.
• On Wednesday, the FDA issued a Safety Alert, informing consumers that after conducting an abbreviated nutrient analysis of Crecelac Infant Powdered Goat Milk Infant Formula, the agency found elevated levels of potassium and chloride as well as low levels of Vitamin A. This product was part of a voluntary recall that the company initiated on May 24, 2024, and all caregivers should have already disposed of the product and discontinued use. If consumers have continued to use this product, the FDA recommends discontinuing any further use of this product.
• On Wednesday, the FDA published a Spotlight on CDER Science describing CDER research that combined the predictive ability of artificial intelligence/machine learning (AI/ML) with appropriate validation processes to develop a method to identify a patient population who will likely benefit from a drug therapy. This was the first time that CDER used AI/ML for a regulatory decision.
• On Wednesday, the FDA published a summary of the adverse event reports (AERs) the agency received about Purina pet food between November 22, 2023, and April 15, 2024. The summary also discusses the FDA’s follow-up activities, including analyzing pet food AERs, pet owner follow-up interviews, testing opened product samples from pet owners and sealed product samples from retail settings, and conducting a facility inspection. The FDA’s summary concluded that there was no direct or consistent connection among the wide range of AERs submitted to the agency. Additionally, the AERs summary found that evidence does not identify a public health concern that could explain the symptoms detailed in the AERs.
• On Wednesday, the FDA issued a Federal Register notice announcing medical device user fees and annual establishment registration fees for Fiscal Year 2025 (FY 2025), effective October 1, 2024, through September 30, 2025. The FDA also announced updates to the small business fee reductions.
• On Wednesday, the FDA issued a letter to health care providers to raise awareness, together with Health Canada, about the safe use of Mega 2000 and Mega Soft Patient Return Electrodes by Megadyne Medical Products, Inc. Since June 2023, Megadyne has initiated four voluntary recalls due to reports of burn injuries in pediatric and adult patients and health care providers. Following the instructions in the manufacturer's recall notifications can help ensure the safe use of these products. 
• On Wednesday, the FDA announced in the Federal Register the fiscal year (FY) 2025 fee rates and payment procedures under the Animal Drug and Animal Generic Drug User Fee Amendments of 2023. The Animal Drug User Fee Act (ADUFA) authorizes the FDA to collect user fees for certain animal drug applications and supplemental applications, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. These resources supplement funding provided by Congressional budget authority to enhance the performance of the review process ensuring that new animal drug products are safe and effective for animals, and that food derived from treated animals will be safe for consumption. The Animal Generic Drug User Fee Act (AGDUFA) was designed to supplement funding provided by Congressional budget authority to enhance the performance of the generic new animal drug review process, which enables the FDA to ensure that generic new animal drug products are safe and effective. 
• On Tuesday, the FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj, Janssen Research & Development, LLC) in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). 
• On Tuesday, the FDA updated the advisory for the Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies (June 2024) to include updated case counts, and a link to a list of store names and locations where the recalled products were available for retail sale. This comes after FDA received numerous reports of retailers continuing to sell the recalled products.

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