November 3, 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

• October 31, 2025 - FDA Acts to Protect Children from Unapproved Fluoride Drug Products
• October 29, 2025 - FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs
• October 24, 2025 - FDA Issues Emergency Use Authorization for New World Screwworm Drug for Dogs
• October 23, 2025 - FDA Publishes Filing Checklists to Prevent Submission Delays
• October 16, 2025 - FDA Awards First-Ever National Priority Vouchers to Nine Sponsors

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:

• 20 mEq Potassium Chloride Injection by Otsuka ICU Medical: Recall - Due To Overwrap Mislabeled As 10 mEq Potassium Chloride Injection
• Update on Hintermann Series H3 Total Ankle Replacement Post-Approval Study Data: FDA Safety Communication
• FDA Announces Expansion of Early Alert Communications to All CDRH Medical Devices

Guidance Documents

• E20 Adaptive Designs for Clinical Trials

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.

FDA Voices

FDA Encourages Development of New, Reliable Alternatives to Animal Testing in Sunscreen

ICYMI!

Create and Keep a Medication List for Your Health

Many people of all ages take medications.  Keeping track of when, how and why you use medications is important for your health and safety.  A medication list is a tool to help you keep track of all the prescription medications, over-the-counter (OTC) drugs, vitamins, and supplements that you take.  Keeping a medication list helps health care professionals know about your current health and minimize medication errors and adverse drug interactions.  It can be a lifesaving tool, especially during an emergency.

Webinars and Virtual Workshops

Cheminformatics Resources of U.S. Governmental Organizations 2025 Workshop

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.

Digital Health Advisory Committee Meeting Announcement

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.

Pediatric Developmental Safety Assessment: New Approach Methods

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.

Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks

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.