July 7, 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:
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!Division of Targeting and Analysis Embraces Greater Challenges, Stronger Collaborations| While millions of Americans drift off to sleep each night, the never-ending deluge of trillions of dollars in foreign-sourced products continues to surge toward our shores and proceed through our points of entry. The need for safe, essential goods, such as vegetables, fruit juice, coffee, and myriad other goods, does not stop for any time or day. |
Webinars and Virtual WorkshopsPediatric Advisory Committee Meeting Announcement
Date: Wed, July 9, 2025; 10 a.m. - 4 p.m. ET
The Pediatric Advisory Committee (PAC) will meet to discuss post-marketing pediatric-focused safety reviews as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109), the Pediatric Research Equity Act of 2003 (Pub. L. 108-155), and the Pediatric Medical Device Safety and Improvement Act of 2007 (Pub. L. 110-85, title III). Clinical Trials Using Patient Health Data: Realities and Myths
Date: Thu, July 10, 2025; 3 - 4 p.m. ET
This talk will examine the role of patient data in the design and evaluation of PCT’s and review some of the issues involved. This will be supported by several useful and diverse examples. 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 FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for 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 FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for 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
The Committee will discuss BLA 761440, belantamab mafodotin submitted by GlaxoSmithKline LLC, for the treatment of adults with multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior line of therapy; and in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide. Reagan-Udall Foundation for the FDA's Annual Public Meeting of its Board of Directors
Date: Thu, July 17, 2025; 9 - 10:30 a.m. ET
FDA Commissioner Martin Makary, joined by Deputy Commissioners Grace Graham and Lowell Zeta, will sit down with Foundation CEO Susan Winckler to discuss the Administration's vision for the FDA and the priorities for the year ahead. Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement
Date: Fri, July 18, 2025; 9 a.m. - 4 p.m. ET
The Committee will discuss supplemental New Drug Application (sNDA) 205422/S-012, for REXULTI (brexpiprazole) tablets, submitted by Otsuka Pharmaceutical Company, Ltd., for the proposed indication of treatment of adults with post-traumatic stress disorder (PTSD), in combination with sertraline. 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 FDA, 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 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 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. | 
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