Updates- September 5, 2025 - FDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for Children
- September 5, 2025 - FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients
- September 5, 2025 - Import Alert 66-80 - Detention Without Physical Examination of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances
- September 4, 2025 - FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89
- September 4, 2025 - Investigations of Foodborne Illness Outbreaks
- September 3, 2025 - FDA Advances Rare Disease Drug Development with New Evidence Principles
- September 2, 2025 - Annual Forecast for Planned Monograph Activities
- September 2, 2025 - Share Oncology Research Topics with FDA
- September 2, 2025 - Warning Letters
MedWatch: 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. 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!| Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection. |
Webinars and Virtual WorkshopsDate: Wed, Sept. 10, 2025; 8 - 9 a.m. ET
The Eco-NAMS webinar series is co-organized by the FDA, U.S. Environmental Protection Agency, European Medicines Agency, Health and Environmental Sciences Institute, National Institute for Environmental Studies (Japan), and PETA Science Consortium International e.V. The series aims to offer the most informative and up-to-date science on the use of new approach methodologies (NAMs) for ecotoxicity assessments (Eco-NAMs) and provides an open forum for scientists from academia, industry, non-government organizations, regulatory authorities, and other interested parties including the general public to learn about and discuss various ecotoxicity NAMs topics. Date: Wed, Sept. 10, 2025; 1 - 5 p.m. ET
FDA and the Duke-Margolis Institute for Health Policy will host a virtual workshop on September 10, 2025, that will delve into the challenges and strategies for expedited chemistry, manufacturing, and controls (CMC) development. The meeting will feature perspectives from both industry leaders and FDA regulators, who will discuss best practices and lessons learned from the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program. Date: Thu, Sept. 11, 2025; 9 a.m. ET
Join virtually the FDA-AACR Workshop: Approach to Novel Oncology Endpoint Development, a one-day meeting that will bring together experts from regulatory agencies, academia, industry, and advocacy to discuss the development and application of novel endpoints in oncology drug development. This collaborative forum will explore scientific and regulatory considerations, emerging data, and future directions for endpoint innovation in cancer research and treatment. Date: Thu, Sept. 11, 2025; noon - 2 p.m. ET
This webinar will provide an in-depth look at the draft ICH M13B guideline titled "Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver" that was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly in March 2025. Date: Webinar Series 2 from Wed, Sept. 3, 2025 - Wed, Sept. 16, 2026; noon ET
The FDA and the Alliance to Stop Foodborne Illness, a non-profit public health organization, are collaborating on a webinar series that explores food safety culture. The series, entitled Collaborating on Food Safety Culture, began on November 4, 2021. The webinar series engages experts from the public and private sectors in a collaborative exchange of ideas and experiences related to the importance of a robust food safety culture in helping to ensure safe food production. The series will have valuable information for both those well-versed on, and those just learning about, food safety culture. Date: Mon, Sept. 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). Date: Wed, Sept. 17, 2025; 9:30 a.m. - 2:30 p.m.
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the FDA, is convening a one-day hybrid public meeting on September 17, 2025, focused on novel efficacy endpoints used in interventional clinical trials for drugs and biologics intended for patients with severe vision loss to support regulatory decision making. The meeting will focus on full-field stimulus threshold testing and ellipsoid zone data. Researchers, clinicians, and other parties will present and discuss evidence and data that may support the use of these tools in regulatory decision-making, such as clinical and statistical considerations for quantifying a clinically meaningful change. Discussion will also include current limitations and potential strategies to advance the use and implementation of these tools to support regulatory decision-making. Date: Thu, Sept. 18, 2025; 9 a.m. - 3 p.m. ET
The FDA is hosting a hybrid in-person/virtual meeting on September 18, 2025, to meet the BsUFA III Commitment to review the progress of the pilot program’s aims, or demonstration projects, and solicit input on future priorities. The meeting agenda includes an overview of the regulatory science program, presentations by internal and external awardees conducting research projects under the BsUFA III regulatory science program, and panel discussions by FDA staff and representatives from the biosimilar industry. Date: Thu, Sept. 18, 2025; 10 a.m. - 4 p.m. ET
The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public listening meeting to solicit perspectives from cell and gene therapy (CGT) manufacturers and other stakeholders on leveraging prior knowledge and experience to facilitate product development and application review. Day 1: Tue, Sept. 18, 2025; 12:30 p.m. - 5 p.m. ET
Day 2: Wed, Sept. 19, 2025; 12:30 p.m. - 4 p.m. ET
On September 18 and 19, 2025, the FDA is hosting a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other areas of greatest interest or concern to public stakeholders. This workshop will feature presentations and panel discussions with experts on selected methodologies and the challenges and opportunities they present. In addition, this workshop will present a draft version of an updated evidence dossier template to facilitate the submission of evidence to FDA to support a Clinical Outcome Assessment. Date: Fri, Sept. 19, 2025; 9 a.m. - 1 p.m. ET
The FDA is hosting a hybrid in-person/virtual public workshop on September 19, 2025, to meet the BsUFA III commitment. The meeting agenda includes presentations by representatives from the biosimilar industry on the future needs for the development of interchangeable products, discussions on specific interchangeable topics, and a panel discussion with industry. Day 1: Tue, Sept. 23, 2025; 8:30 a.m. - 5:30 p.m. ET
Day 2: Wed, Sept. 24, 2025; 8:30 a.m. - 4:20 p.m. ET
This 2-day hybrid workshop addresses challenges in particle size characterization for complex generic drug products. It aims to enhance understanding of Dynamic Light Scattering (DLS) and Laser Diffraction (LD) techniques, tackle method development and validation issues, and provide hands-on experience with equipment. By bringing together industry experts, regulatory scientists, and instrument vendors, the workshop fosters collaboration to overcome hurdles in generic drug development, identify research needs, and improve regulatory guidance. Participants will gain valuable insights through theoretical presentations, practical demonstrations, and interactive discussions. Date: Wed, Sept. 24, 2025; 9 a.m. - noon ET
The FDA is holding a hybrid public meeting titled "Prescription Drug User Fee Act and Biosimilar User Fee Amendments Hiring and Retention Assessment." The meeting includes an opportunity for public comment. This public meeting is being held to meet performance commitments included in the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Amendments (BsUFA III). During the public meeting, FDA will share high-level findings from a third-party assessment of FDA’s hiring and retention of staff for the human drug review program conducted by an independent contractor, Eastern Research Group, Inc. (ERG). Date: Tue, Sept. 23, 2025; 9:30 a.m. - 3 p.m. ET
During this meeting, experts will discuss lessons learned from case studies in which RWE was used for regulatory decision-making for medical products. Speakers will highlight FDA’s efforts with RWD/E to date and approaches to generate RWE to meet regulatory requirements. This convening fulfills both a PDUFA VII and a MDUFA V requirement. Date: Tue, Sept. 30, 2025; 9 a.m. - 4 p.m. ET
In response to Executive Order (EO) 14293, FDA has developed a proposal, FDA PreCheck to accelerate the establishment of high priority new pharmaceutical manufacturing facilities in the U.S. and strengthen the domestic pharmaceutical supply chain. Specifically, the proposal consists of a two-phase approach: (1) Facility Readiness Phase, and (2) Application Submission Phase. In Phase 1, the Facility Readiness Phase, selected manufacturers can engage with FDA for early technical advice before a facility is operational through pre-operational reviews and utilization of a facility-specific Drug Master File to facilitate efficient evaluation of facility-specific elements prior to, and in support of, the submission of a drug application. In Phase 2, the Application Submission Phase, FDA and applicants build upon Phase 1 and engage through pre-submission meetings to resolve issues and expedite assessments of quality information in a drug application and inspections. Date: Tue, Sept. 30, 2025; 9:30 - 10:40 a.m. ET
This meeting will provide FDA the opportunity to update interested public stakeholders on topics related to the financial management of PDUFA VII, BsUFA III, and GDUFA III. This year, FDA will present the 5-year financial plans for each of these programs and update participants on the progress towards implementing resource capacity planning as part of fee setting and modernized time reporting. Date: Tue, Oct. 7, 2025; 9 a.m. - 4:30 p.m. ET
The Center for Tobacco Products’ TPSAC will meet for an open session to discuss the renewal of modified risk granted orders issued to Philip Morris Products S.A. for the following products:
- Marlboro Amber HeatSticks
- Marlboro Green Menthol HeatSticks
- Marlboro Blue Menthol HeatSticks
- IQOS 2.4 System Holder and Charger
- IQOS 3.0 System Holder and Charger
Discussion will focus on whether the statutory standards continue to be met. Date: Tue, Oct. 7, 2025; 9 a.m. ET
Be a part of a dynamic conversation as leading experts dive into the rapidly evolving role of AI in transforming drug and biological product development — spotlighting the evolving role of AI in advancing the safety, efficacy, and quality of drug and biological product development. Drawing on real-world breakthroughs since the first workshop in 2024, our speakers will address best practices, highlight cross-disciplinary collaborations, and reveal creative strategies to boost data quality, reduce bias, and enhance transparency and performance in AI models. Discover fresh opportunities for partnership and walk away with actionable steps to drive responsible, transformative uses of AI in clinical research and to support regulatory decisions. Day 1: Tue, Oct. 7, 2025; 9 a.m. - 4 p.m. ET
Day 2: Wed, Oct. 8, 2025; 9 a.m. - 3 p.m. ET
Join us for the 2025 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. Dissect complex scientific challenges in abbreviated new drug applications (ANDAs) alongside FDA experts, and gain insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues related to product-specific guidance development, as well as pre-ANDA and ANDA meeting discussions. The workshop will also highlight innovative science and cutting-edge methodologies in generic drug development. Date: Fri, Oct. 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. Date: Thu, Oct. 23, 2025; 8:30 a.m. - 4 p.m. ET
This public workshop is intended to provide information about and gain perspective from health care providers, academia, and industry on approaches used for the review and approval of new patch test allergens for the diagnosis of allergic contact dermatitis. The input from this public workshop will help inform the Agency on the need for rapid approval of new patch test allergens, the utility of the Agency’s current approval paradigm, and proposals for alternative approaches that might be considered. Day 1: Wed, Nov. 5, 2025; 9 a.m. - 4:30 p.m. ET
Day 2: Thu, Nov. 6, 2025; 9 a.m. - 4:30 p.m. ET
Day 3: Thu, Nov. 7, 2025; 9 a.m. - 4:30 p.m. ET
The purpose of the Cheminformatics Resources of U.S. Governmental Organizations 2025 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: Fri, Dec. 5, 2025; 8 a.m. - 4 p.m. ET
The FDA in collaboration with the Triangle Center of Excellence in Regulatory Science and Innovation (Triangle CERSI) will host a public workshop entitled “Hybrid Public Workshop: Pediatric Developmental Safety Assessment and New Approach Methodologies” on December 5, 2025. The goal of this workshop is to discuss new approach methods that can address pediatric developmental safety during drug development. 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. |
