March 4, 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

• February 28, 205 - FDA Issues Class-wide Labeling Changes for Testosterone Products
• February 26, 2025 - Advances in FDA's Drug Safety Programs

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:

• Wild Coast Raw Boneless Free Range Chicken Formula Raw Pet Food: Recall - Because of Bird Flu Health Risk
• Endovascular System Recall: Philips Removes and Discontinues Distribution of Tack Endovascular System Due to User Challenges That Caused Additional Procedures to Reposition or Remove Implant
• Vaporizer Recall: Getinge Removes Vaporizer Sevoflurane Quick-Fil and Expands Recall of Vaporizer Sevoflurane Maquet Filling due to Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride
• Ablation Catheter Correction: Biosense Webster Updates Use Instructions for Varipulse Due to High Rate of Stroke or Transient Ischemic Attack
• Patient Table Correction: Philips Updates Use Instructions for Allura and Azurion Systems due to Patient Fall Risk from Incorrectly Positioned Mattresses
• Power Assist Device Recall: Max Mobility/Permobil Removes SpeedControl Dial Component Used with SmartDrive MX2+ Power Assist Device Due to Risk for Motor to Be Unresponsive to the User
• Regard Newborn Kit Recall: ROi CPS, LLC Removes Certain Newborn Kits Due to a Recalled Component, the Neo-Tee T-Piece Resuscitator with an Undersized Controller Spring
• Endoscope Instrument Recall: Olympus Removes Single Use Guide Sheath Kits Due to Risk for Radiopaque Guide Sheath Tip Detaching During Procedures
• SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System by Ascent Consumer Products: Recall - Due to Microbial Contamination
• Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags by Central Admixture Pharmacy Services (CAPS): Recall - Due to Visible Black Particulate Matter in a Single-Sealed Vial
• Vitafer-L Gold Liquid by Natural Dior: Recall - Due to Presence of Undeclared Tadalafil

Consumer Updates

A Fresh Take on What "Healthy" Means on Food Packages

With so many food options out there, it is helpful to have information on food packages that can empower you to identify healthier choices.

Guidance Documents

Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators

Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs

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.

Webinars and Virtual Workshops

Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions

March 13, 2025; 1:00 - 3:00 p.m. ET

This event will provide an update on FDA’s efforts related to model master files (MMFs). The agenda includes presentations by FDA staff that will focus on an introduction and overview of MMFs, considerations for developing and submitting MMFs to support ANDAs using a Type V DMF, and a cross-comparison to other types of DMFs, including lessons learned.

Optimizing Pregnancy Registries

March 27 - 28, 2025

Day 1: Thu, Mar 27; 9:00 a.m. - 4:00 p.m. ET
Day 2:  Fri, Mar 28; 9:00 a.m. - Noon ET

The purpose of the public workshop is to discuss challenges in designing and implementing pregnancy registries and to consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy. This public workshop is being held in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) program.

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.