Updates
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September 25, 2025 - FDA Approves Imlunestrant for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer
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September 25, 2025 - FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Pediatric Myopia
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September 25, 2025 - FDA Advisory: Do Not Feed Two Lots of Darwin's Natural Pet Products BioLogics Dog Food Due to Salmonella and Listeria monocytogenes
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FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)
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September 25, 2025 - Outbreak Investigation of Salmonella: Deep-brand Frozen Products (July 2025)
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September 25, 2025 - FDA Response to Imported Foods Potentially Contaminated with Cesium-137
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September 25, 2025 - Radionuclides in Domestic and Imported Foods
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September 25, 2025 - Compliance Policy Guide for Radionuclides in Domestic and Imported Foods
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September 24, 2025 - FDA Provides Additional Transparency Around Foodborne Outbreaks and Investigations by Sharing Executive Incident Summary Abstracts for Foodborne Illnesses and Foodborne Outbreak Overview of Data (FOOD) Reports
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September 24, 2025 - Foodborne Illness Outbreak Executive Incident Summary Abstracts
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September 24, 2025 - Foodborne Outbreak Overview of Data (FOOD) Reports
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September 24, 2025 - Investigations of Foodborne Illness Outbreaks
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September 23, 2025 - Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned
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September 23, 2025 - Warning Letter - Stellalife, Inc.
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September 23, 2025 - FDA Advises Public Not to Eat, Sell, or Serve Certain Imported Frozen Shrimp from an Indonesian Firm
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September 22, 2025 - FDA use of Real-World Evidence in Regulatory Decision Making
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September 22, 2025 - FDA Takes Action to Make a Treatment Available for Autism Symptoms
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September 22, 2025 - FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
The 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 here:
Guidance Documents
View 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.
 Clinical trial transparency is fundamental to maintaining public trust in medical research and supports broader scientific advancements among the global clinical research community. The U.S. Food and Drug Administration is keenly focused on clinical trial transparency, which is an ethical obligation under the Declaration of Helsinki and rooted in the fundamental principles of medical research. The Declaration of Helsinki establishes ethical principles for medical research involving human subjects and serves as a cornerstone document for the international medical community, providing guidance on issues such as informed consent and the protection of vulnerable populations in clinical trials. This declaration emphasizes that data transparency is essential for enabling scientific advancements and protecting research participants' rights and well-being.
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The mission of the Oncology Center of Excellence Pediatric Oncology Program is to promote the development of safe and effective new drugs and biologics to treat cancer in children. |
Webinars and Virtual Workshops
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: 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: Mon, Oct. 6, 2025; 10 a.m. - noon ET
The FDA Expert Panel on Food Allergies will facilitate discussions on the cause of and best treatments for food allergies as well as current health guidelines.
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.
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Date: Tue, Oct. 7, 2025; 9 a.m. ET
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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.
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Day 1: Tue, Oct. 7, 2025; 9 a.m. - 4 p.m. ET
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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: Wed, Oct. 8, 2025 - 1 - 3:30 p.m. ET
The FDA Oncology Center of Excellence (OCE) Patient-Focused Drug Development (PFDD) program welcomes you to the Clinical Outcome Assessment in Cancer Clinical Trials (COA-CCT) 10th annual workshop. Each year, the COA-CCT workshop provides a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the regulatory and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials. This workshop will review the FDA guidance on core PROs, finalized in 2024, and discuss how these core outcomes have been used to describe patient experience using recent examples from oncology product labeling.
Date: Thu, Oct. 9, 2025 - 8:30 a.m. - 6 p.m. ET
On October 9, 2025, the Committee will meet in open session to discuss and make recommendations on the following separate topics. Under Topic I, the Committee will discuss and make recommendations on the strain selection for the influenza virus vaccines for the 2026 Southern Hemisphere influenza season. Under Topic II, the Committee will discuss and make recommendations on advancing CBER’s allergen standardization program.
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.
Day 1: Wed, Oct. 15, 2025; 8:30 a.m. - 5:10 p.m. ET
Day 2: Thu, Oct. 16, 2025; 8:30 a.m. - 3:40 p.m. ET
Artificial Intelligence (AI) is rapidly transforming drug development and regulatory processes across the pharmaceutical industry. This workshop explores cutting-edge applications of modeling and AI throughout the drug development lifecycle, with particular emphasis on complex generics. Through presentations, panel discussions, and interactive sessions, attendees will examine how AI is being integrated into regulatory frameworks to streamline workflows, accelerate development timelines, and advance quantitative medicine approaches.
Date: Wed, Oct. 22, 2025; noon - 1:30 p.m. ET
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting its next virtual town hall on October 22, 2025. During this town hall, OTP’s Office of Gene Therapy will partner with experts from CBER’s Office of Compliance and Biologics Quality’s Division of Manufacturing and Product Quality (DMPQ) to answer questions regarding CMC and facility readiness for BLA submissions and post-licensure changes for gene therapy manufacturing facilities.
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.
Date: Thu, Oct. 30, 2025; 10 a.m. - noon ET
On Thursday, October 30, 2025, the FDA’s Center for Veterinary Medicine (CVM) will host a virtual public meeting to provide an overview of a third-party assessment that examines the implementation of the Animal Drug User Fee Act (ADUFA). This public meeting is virtual only. The virtual meeting will be available via a webcast link that registrants will receive after completing registration.
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: Fri, 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: Thu, Nov. 6, 2025; 9 a.m. - 6 p.m. ET
The FDA announces a forthcoming public advisory committee meeting of the Digital Health Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA. The meeting will be open to the public. The FDA is establishing a docket for public comment.
Day 1: Tue, Nov. 18, 2025; 10:45 a.m. - 4 p.m. ET
Day 2: Wed, Nov. 19, 2025; 10 - 11:30 a.m. ET and 2 - 3:30 p.m. ET
Day 3: Thu, Nov. 20, 2025; 10 - 11:30 a.m. ET and 2 - 3:30 p.m. ET
The FDA will host, in collaboration with various stakeholders, including industry, consumer groups, healthcare professionals, individual firms, retailers, and academic researchers, a virtual public meeting followed by virtual listening sessions to help inform the FDA’s next steps, prioritize potential options, and advance our food allergen threshold approaches to benefit public health.
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.
Day 1: Wed, Dec. 10, 2025; 1- 5 p.m. ET
Day 2: Thu, Dec. 11, 2025; 8:30 a.m. - 4:00 p.m. ET
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 Us
The 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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