June 23, 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 DirectNew! Episode 9: This Week at the FDA!| In this episode of FDA Direct, we cover key updates straight from the top – including Commissioner Makary’s presence at the BIO Conference and the FDA’s continued engagement with industry leaders at the CEO Forum in Boston. Plus, we break down the latest announcements on priority review vouchers to the FDA reviewing new clinical trials that export Americans’ cells to foreign labs in hostile countries for genetic engineering. |
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 is still accepting applications until June 30, 2025, for the Rare Disease Endpoint Advancement (RDEA) Pilot Program which supports novel efficacy endpoint development for drugs that treat rare diseases. Webinars and Virtual WorkshopsPediatric Advisory Committee Meeting Announcement
Date: Wed, July 9, 2025; 10 a.m. - 4 p.m. ET
Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. 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. Meeting of the Oncologic Drugs Advisory Committee
Date: Thu, July 17, 2025; 8 a.m. - 12:45 p.m. ET
Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement
Date: Fri, July 18, 2025; 9 a.m. - 4 p.m. ET
Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population
Date: Wed, July 23, 2025; 9:30 a.m. - 4 p.m. ET
The Reagan-Udall Foundation for the FDA, in cooperation with the Food and Drug Administration, will convene a hybrid public meeting to gather input on the clinical use and safety concerns associated with orally ingestible unapproved prescription drug products containing fluoride for use in children. Register for the FDA’s Public Meeting on the Reauthorization of the Medical Device User Fee Amendments
Date: Mon, August 4, 2025; 10 a.m. - 3 p.m. ET
The U.S. Food and Drug Administration (FDA) is announcing a public meeting on the reauthorization of the Medical Device User Fee Amendments for fiscal years 2028 through 2032 (MDUFA VI). Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act
Date: Mon, September 15, 2025; 9 a.m. - 4:30 p.m. ET
The purpose of the public meeting is to seek input from interested parties including, patient/parent/caregiver groups, consumer groups, regulated industry, academia, and others. This input will enable FDA to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, including pediatric drug and biologic development and labeling, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA/The Osteosarcoma Institute (OSI) Workshop: Advancing Osteosarcoma Drug Development – Connecting Research and Regulatory Pathways for Improved Outcomes
Date: Fri, October 10, 2025; 9:30 a.m. - 5 p.m. ET
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) and The Osteosarcoma Institute (OSI) have a shared interest in engaging with the osteosarcoma community to identify the major barriers to drug development for osteosarcoma and to discuss opportunities for collaboration to address these challenges. 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. | 
