FDA Roundup: September 6, 2024

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

• On Sept. 11 from 1-2 p.m. ET, the FDA will host a virtual Medical Device Sterilization Town Hall: Sterility Master Files and Effective Use in Premarket Submissions. Registration is not required to attend.
• Today, the FDA issued a draft guidance “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle”. This guidance, when finalized, is intended to provide recommendations on how patient preference information might be collected and shared with the FDA and potentially be considered in FDA decision-making processes. It also provides recommendations on designing patient preference studies that may provide reliable scientific evidence. On Oct. 15, 2024, the FDA will host a webinar for industry and other parties interested in learning more about the draft guidance. Please submit comments under docket number FDA-2015-D-1580 at www.regulations.gov by Dec. 5, 2024, to ensure the FDA considers comments before it begins work on the final version of the guidance.
• On Thursday, the FDA updated the advisory, Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies (June 2024), to include updated case counts and additional product sample results. 
• On Wednesday, the FDA issued a Constituent Update detailing efforts to enhance food traceability. Deputy Commissioner Jim Jones highlighted the FDA’s online resources regarding the Food Traceability Rule, as well as roundtables with the Reagan-Udall Foundation aimed at aiding industry implementation of the Rule. Insights from these discussions will be further explored in an upcoming public meeting on Oct. 7. Stakeholders are encouraged to participate and provide feedback through Oct. 25. For registration details and further information about attending the public meeting please visit the Foundation website.
• On Wednesday, the FDA started accepting site proposals for the Fall 2025 cycle of the Experiential Learning Program (ELP). Through this collaborative learning experience, sites host the Center for Devices and Radiological Health (CDRH) staff (virtually or in-person) and share with them valuable insights about medical devices, emerging technologies, industry practices, and patient needs. CDRH welcomes site proposals from medical device manufacturers, academia, clinical facilities, medical device incubators and accelerators, health technology assessment groups, and other medical device interested parties, including those that have previously participated in the ELP or other FDA programs. Please submit site proposals for ELP’s Fall 2025 cycle before Monday, Oct. 7 at noon ET.
• On Wednesday, the FDA shared tips about protecting public health and the health of individuals throughout emergencies and disasters in support of National Preparedness Month. There’s no better time for medical device manufacturers, distributors, and health care providers to prepare for unexpected events. Start by reviewing best practices to minimize supply chain disruptions and ensure continued availability, delivery, and use of medical devices. For any manufacturing and quality problems, delays, discontinuances, or interruptions of a medical device, please notify the FDA about a medical device supply issue.
• On Wednesday, the FDA released its annual Pesticide Residue Monitoring Program Report for Fiscal Year 2022, summarizing findings from the FDA’s testing of human and animal foods for 757 different pesticides and selected industrial compounds from Oct. 1, 2021, through Sept. 30, 2022. 
• On Wednesday, the FDA issued a Dear Veterinarian letter describing Federal requirements related to a veterinarian’s role in dispensing prescription animal drugs and to the establishment of a veterinarian-client-patient relationship in the course of practice, including telemedicine.
• On Tuesday, the FDA published a Spotlight on CDER Science highlighting a qualitative study conducted by CDER and outside researchers that explored how health care providers (HCPs) consider a boxed warning (BW) when they are making treatment decisions for their patients, and how HCPs communicate with patients about BW information. Findings from this study underscore the nuanced complexity and context-specific nature of individual patient benefit–risk decisions.
• On Tuesday, the FDA posted a new video in the “FDA In Your Day” series. In this video, Chief Medical Officer, Dr. Hilary Marston discusses hurricane preparedness.

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