June 2, 2025
Dear Colleague,
The FDA works to safeguard the public against potential health risks, ensures the safety and efficacy of medical products, and the safety of our nation’s food supply and cosmetics. Your partnership, knowledge and engagement in the public health space are appreciated.
Sincerely,
The Public Engagement Staff
Public Engagement Staff | FDA UpdatesMedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe FDA’s medical product safety reporting program for health professionals, patients and consumers. MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products. The most recent alerts/recalls are:
FDA Direct| FDA Commissioner Marty Makary, M.D., M.P.H. and other members of FDA leadership, as well as guests, engage in timely and frank discussions to bring you an inside look at the current happenings at the FDA. |
Guidance DocumentsView all Official FDA Guidance Documents and other Regulatory Guidance
You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period. ICYMI!FDA Agents Bust Man Selling Illegal and Unsafe Bodybuilding Drugs| When it comes to illegal activities involving FDA-regulated products, FDA’s Office of Criminal Investigations (OCI) protects the American public by conducting criminal investigations, arresting those responsible, and bringing them before the Department of Justice for prosecution. |
Webinars and Virtual WorkshopsFiscal Year 2025 Generic Drug Science and Research Initiatives Public Workshop
Date: June 3 - 4, 2025
Day 1: Tue, June 3, 2025; 8 a.m. - 5:30 p.m. ET
Day 2: Wed, June 4, 2025; 9 a.m. - 4:30 p.m. ET
The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA Expert Panel on Infant Formula
Date: Wed, June 4, 2025; 10 a.m. - noon ET
FDA Commissioner Marty Makary, M.D., M.P.H. will lead a roundtable discussion of an independent panel of scientific experts to discuss infant formula.
Space is limited. Registration is only required for in-person attendance. Please use the link below to register and plan to arrive at least 30 minutes prior to the start time to be checked in. Please use the button below to view via livestream. Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA)
Date: Fri, July 11, 2025; 9 a.m. - 2 p.m. ET
The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 through 2032. Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA)
Date: Mon, July 14, 2025; 9 a.m. - 2 p.m. ET
The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032. CVM Public Meeting: Second Annual Animal Drug User Fee Educational Conference
Date: Tue, July 15, 2025; 9 a.m. - 5 p.m. ET
FDA’s Center for Veterinary Medicine (CVM) will host the second meeting in a series of five public meetings to provide educational sessions for stakeholders who are interested in the new animal drug approval process. View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts About UsThe Public Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations. For more information, please contact us at: PublicEngagement@fda.hhs.gov. For patient specific inquiries, please contact us at: Patients Ask FDA. |
