July 28, 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 Updates- July 28, 2025 - RUF Releases Produce Safety Roadmap: A Call for Action
- July 28, 2025 - Docket Open for Public Comments on the Risks and Benefits Related to Menopause Hormone Therapy
- July 25, 2025 - FDA Investigating Death of 8-Year-Old Boy Who Received Elevidys
- July 24, 2025 - FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Frozen, Raw, Half-Shell Oysters from Republic of Korea Potentially Contaminated with Norovirus
- July 24, 2025 - The FDA has Released the Regulatory Accelerator
- July 24, 2025 - Outbreak Investigation of Listeria monocytogenes: Ready-to-Eat Foods (May 2025)
- July 24, 2025 - The FDA Oncology Center of Excellence (OCE) has Announced a Request for Applications to Support Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics
- July 24, 2025 - Outbreak Investigation of Salmonella: Frozen Sprouted Beans (July 2025)
- July 23, 2025 - HHS, FDA Praise Consumer Brands Association’s Vow to Remove Artificial Colors from America’s Food Supply
- July 23, 2025 - HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods
- July 23, 2025 - FDA Issues White Paper on Selective Safety Data Collection
- July 22, 2025 - Registration & Listing of Cosmetic Product Facilities and Products
- July 22, 2025 - Commissioner's National Priority Voucher (CNPV) Pilot Program
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. 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. FDA Direct FDA Welcomes Dr. Tidmarsh as Center for Drug Evaluation and Research (CDER) DirectorNew! FDA Direct, Episode 13 - Stanford Physician-Scientist: FDA welcomes Dr. Tidmarsh as CDER Director
Listen as FDA Commissioner, Dr. Marty Makary, speaks with Dr. George Tidmarsh, the new Director of FDA’s Center for Drug Evaluation and Research about the future of drug regulation at the FDA. |
ICYMI!July is Fibroids Awareness Month| FDA Office of Women’s Health (OWH) is raising awareness about uterine fibroids—the most common non-cancerous tumors that grow in and around the wall of the uterus of women of childbearing age. OWH offers a range of resources to promote education, awareness, and advance research on uterine fibroids—including a fact sheet, educational and personal story videos, and information on treatment options to support informed care. |
Webinars and Virtual WorkshopsFDA Grand Rounds – Forensic Proteomics Applied to FDA-Regulated Products
Date: Thu, July 31, 2025; noon - 1 p.m. ET
Proteins and peptides are being increasingly used in therapeutic formulations. This presentation will discuss the techniques utilized at the National Forensic Chemistry Center to analyze proteins and peptides in FDA-regulated products. Register for the FDA’s Public Meeting on the Reauthorization of the Medical Device User Fee Amendments
Date: Mon, Aug. 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). General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Date: Wed, Aug. 13, 2025; 9 a.m. - 3:30 p.m. ET
On August 13, 2025, the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Committee) will discuss a new indication for use for dermal filler devices in the décolletage area and will make recommendations regarding risks associated with new indications for use such as in the décolletage area, the potential impact of filler material on imaging studies and clinical exams (e.g., breast cancer screening), pre-market and post-market study assessments for benefit and risk, removal of dermal filler implant material, and patient preference. Compounding Quality Center of Excellence | Annual Conference
Day1: Mon, Aug. 25, 2025; 2 - 5 p.m. ET
Day 2: Wed, Aug. 27, 2025; 9 a.m. - 6 p.m. ET
Day 3: Thu, Aug. 28, 2025; 9 a.m. - 4:30 p.m. ET
FDA’s Compounding Quality Center of Excellence will host its sixth Annual Conference. Participants can attend this free, hybrid conference in person at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland, or virtually. The conference will convene outsourcing facilities, pharmacy compounders and others from across the industry to discuss emerging trends and best practices through presentations, panels and interactive sessions. Collaborating on Food Safety Culture
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. Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act
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). FDA Public Meeting: BsUFA III Regulatory Science Program Interim Public Meeting
Date: Thu, Sept. 18, 2025; 9 a.m. - 3 p.m. ET
The U.S. Food and Drug Administration (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. FDA CBER OTP Public Listening Meeting: Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies
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. FDA Public Workshop: Future Needs for the Development of Interchangeable Products
Date: Fri, Sept. 19, 2025; 9 a.m. - 1 p.m. ET
The U.S. Food and Drug Administration (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. FDA/The Osteosarcoma Institute (OSI) Workshop: Advancing Osteosarcoma Drug Development – Connecting Research and Regulatory Pathways for Improved Outcomes
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. 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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