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 here:
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 encourages consumers, veterinarians and industry to report problems with animal drugs, food and devices. Webinars and Virtual WorkshopsDate: Wednesday, Dec. 3, 2025; 9 a.m. - noon ET
The FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological products. Date: Wednesday, Dec. 3, 2025; 9 a.m. - 6 p.m. ET
The FDA announces a forthcoming virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on the FDA’s regulatory issues. The Committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) sponsored by V-Wave, Inc. for the V-Wave Ventura Interatrial Shunt System, which is a first-of-a-kind device permanent implant designed to shunt blood from the left to the right atrium to improve symptoms in patients with advanced chronic heart failure. The meeting will be open to the public. The FDA is establishing a docket for public comment. Date: Friday, Dec. 5, 2025; 8 a.m. - 4 p.m. ET
The goal of this workshop is to discuss new approach methods that can address pediatric developmental safety during drug development. Date: Wednesday, Dec. 10, 2025; 9 a.m. - 3:30 p.m. ET
On December 10, 2025, the Advisory Committee will meet virtually to deliberate and make recommendations on issues related to an emerging technology in the context of medical devices and germicidal ultraviolet (UV) light as a mode of disinfection. The FDA is seeking to obtain feedback to improve the total product life cycle (TPLC) evaluation of UV disinfection devices. In addition, the Committee will meet to discuss and provide advice to the FDA on devices used in pandemic preparedness and response to satisfy, in part, a requirement under the Food and Drug Omnibus Reform Act of 2022 (FDORA). Date: Wednesday, Dec. 10, 2025; 1 - 3 p.m. ET
FDA Expert Panels are roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and individual experts may offer their recommendations for regulatory action. This initiative is part of the FDA’s broader efforts to apply rigorous, evidence-based standards to modernize regulatory oversight, while considering evolving science and consumer health. The FDA Expert Panel on Testosterone Replacement Therapy for Men will facilitate discussions on the risks and benefits related to testosterone replacement therapy. Date: Thursday, Dec. 11, 2025; 9 - 10:30 a.m. ET
This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs. Attendees will gain insights into the USP standards development process and learn how they can sponsor or participate—via public comment—in the development of future standards. Date: Thursday, Dec. 11, 2025; 11 a.m. - noon ET
As the global population ages, healthcare providers increasingly encounter unique challenges in tailoring cancer treatments for older patients. The landscape of cancer care for older adults is complex and multifaceted. It's where personal values and life experiences intersect with medical expertise and technological capabilities. The session will explore this intricate tapestry of decision-making in geriatric oncology, emphasizing patient-centered decision-making processes. Date: Tuesday, Dec. 16, 2025; 9 a.m. - 4:30 p.m. ET
This hybrid public workshop will initiate a discussion on expanding epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality. Date: Application Deadline Monday, Dec. 29, 2025, 3 p.m. CT
The FDA and ASPHO have partnered to cosponsor an 8-month interactive educational program designed for early career pediatric hematology/oncology clinicians and researchers. This program addresses a critical gap in training by providing learners with a foundational understanding of pediatric hematology/oncology drug-development and the regulatory review process. Day 1: Monday, Jan. 5, 2026; 9 a.m. - 4:30 p.m. ET
Day 2: Tuesday, Jan. 6, 2026; 9 a.m. - 4:30 p.m. ET
Day 3: Wednesday, Jan. 7, 2026; 9 a.m. - 4:30 p.m. ET
The purpose of the Cheminformatics Resources of U.S. Governmental Organizations 2026 Workshop is to enhance communication and collaboration between the U.S. Government-funded organizations that create and maintain databases, data standards, datasets, scientific approaches and computational resources dealing with chemical structures and properties of molecules and materials. Date: Thursday, Jan. 22, 2026; 9 a.m. - 4:30 p.m. ET
Center for Tobacco Products’ TPSAC will meet virtually for an open session, during which the Committee will discuss modified risk tobacco product applications submitted by Swedish Match USA, Inc. for the following products, each available in two strengths (3 milligrams and 6 milligrams). Discussion will focus on evidence related to the relative health risks of the products, consumer understanding and perceptions of the applicant’s proposed modified risk claim, and the potential public health impact of a modified risk marketing order. Day 1: Thursday, Feb. 5, 2026; 1:30 - 5 p.m. ET
Day 2: Friday, Feb. 6, 2026; 8:30 a.m. - 4 p.m. ET
The FDA, in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI), is announcing the following public workshop titled "Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks." The aim of the public workshop is to discuss common challenges in neonatal and rare disease product development and identify opportunities to leverage rare disease product development frameworks in the neonatal product development space. 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. | 
