June 2, 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

• May 30, 2025 - Outbreak Investigation of Salmonella: Cucumbers (May 2025)
• May 28, 2025 - CEO Forums: An FDA Listening Tour to Engage Pharma CEOs
• May 22, 2025 - A Review of the President’s Fiscal Year 2026 Budget Request for the Food and Drug Administration - Senate Testimony

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 are:

• Bedner Growers, Inc. Recalls Cucumbers Because of Possible Health Risk
• FDA Advises Consumers, Retailers, and Distributors Not to Eat, Sell, or Serve Products from Pan-African Food Distributors Inc. dba East Africa Boutique LLC
• Cetirizine or Levocetirizine: Drug Safety Communication
• UPDATE: Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems

FDA Direct

Guidance Documents

• M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver
• Replacing Color Additives in Approved or Marketed Drug Products
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
• Electronic Submission Template for Medical Device Q-Submissions

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.

ICYMI!

FDA Agents Bust Man Selling Illegal and Unsafe Bodybuilding Drugs

Webinars and Virtual Workshops

Fiscal Year 2025 Generic Drug Science and Research Initiatives Public Workshop

Date: June 3 - 4, 2025

Day 1: Tue, June 3, 2025; 8 a.m. - 5:30 p.m. ET
Day 2: Wed, June 4, 2025; 9 a.m. - 4:30 p.m. ET

The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.

FDA Expert Panel on Infant Formula

Date: Wed, June 4, 2025; 10 a.m. - noon ET

FDA Commissioner Marty Makary, M.D., M.P.H. will lead a roundtable discussion of an independent panel of scientific experts to discuss infant formula.

Space is limited.  Registration is only required for in-person attendance.  Please use the link below to register and plan to arrive at least 30 minutes prior to the start time to be checked in.

Please use the button below to view via livestream.

Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA)

Date: Fri, July 11, 2025; 9 a.m. - 2 p.m. ET

The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 through 2032.

Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA)

Date: Mon, July 14, 2025; 9 a.m. - 2 p.m. ET

The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032.

CVM Public Meeting: Second Annual Animal Drug User Fee Educational Conference

Date: Tue, July 15, 2025; 9 a.m. - 5 p.m. ET

FDA’s Center for Veterinary Medicine (CVM) will host the second meeting in a series of five public meetings to provide educational sessions for stakeholders who are interested in the new animal drug approval process.

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.