The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders.  You can read the FDA regulatory update for stakeholders below.

June 9, 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

• June 6, 2025 - Outbreak Investigation of Salmonella: Eggs (June 2025)
• June 4, 2025 - FDA Advises Consumers Not to Inhale Nitrous Oxide Products
• June 4, 2025 - FDA Updates Tobacco Application Forms; Requires Use by July 6
• June 4, 2025 - Reauthorization of the Over-the-Counter Monograph Drug User Fee Program
• June 3, 2025 - FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer
• June 3, 2025 - FDA Advises Consumers, Retailers, and Distributors Not to Use, Eat, Sell, or Serve Products from Pan-African Food Distributors Inc. dba East Africa Boutique LLC
• June 2, 2025 - FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People

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:

• Flexible Tracheostomy Tube Recall: Medtronic Removes Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula Due to Risk for Disconnection of the Flange from the Device Cannula
• Anesthesia Breathing Circuit Correction: Draeger, Inc. Updates Instructions for Use for VentStar Flex and Anesthesia Circuit Kits Due to Cracks That May Lead to Inadequate Ventilation 
• Infusion Pump Correction: Baxter Issues Correction for Novum IQ Large Volume Pump due to Potential for Underinfusion
• Sulfamethoxazole / Trimethoprim Tablets USP, 400 mg/80 mg Only by Amneal Pharmaceutical: Recall - Due to Microbial Contamination
• Class I Recall Notices: Three Infusion Pump Corrections from Smiths Medical

FDA Direct

Guidance Documents

• M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol
• Hernia Mesh – Package Labeling Recommendations
• M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
• Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers
• CVM GFI #287 - Raw Data for Safety and Effectiveness Studies
• Recommendations for Complying with Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs

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!

Improving U.S. Drug and Medical Product Quality: What Manufacturers Should Focus On

As patients, we expect our medicines, vaccines, medical devices, and other life-saving treatments and products to be safe, effective, and of the highest quality.  At the FDA’s Office of Inspections and Investigations (OII), it’s our job to make sure you and your family have access to products that meet such standards.  We do this through our risk-based oversight of industry, which includes, among other things, in-person inspections inside medical product facilities.  Our regulatory inspections can result in the identification of issues that could otherwise threaten medical product safety and integrity.

Webinars and Virtual Workshops

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.