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 21, 2025 - FDA Approves First Treatment for Cerebrotendinous Xanthomatosis, a Rare Lipid Storage Disease
• February 14, 2025 - FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
• February 11, 2025 - FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Oysters from Louisiana Harvest Area 3, Potentially Contaminated with Norovirus
• February 5, 2025 - FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices
• January 30, 2025 - FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

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:

• ChloraPrep Clear 1 mL Applicators by BD: Recall - Due to Fungal Contamination
• Potassium Chloride Injection, 10 mEq and 20 mEq by ICU Medical: Recall - Due to Mislabeling
• Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal
• Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR-4 Phasitron Breathing Circuits Due to Venturi Component Malfunctions that May Reduce Pressure and Volume Flow
• Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular
• The FDA’s Latest Updates on Breast Implant Safety and Effectiveness
• Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters Due to Excess Material at Catheter Hub that May Detach
• One Lot of Fentanyl Transdermal System, 25 mcg/hr by Alvogen: Recall - Due to a Defective Delivery System
• Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks and/or Leaks in Stopcocks
• Potential to Miss Critical Safety Alerts for Smartphone-Compatible Diabetes Devices
• Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator Due to the Devices Spontaneously Catching Fire
• Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator Due to a Nonconforming Battery Charger, Which Triggers a Battery Alarm and Renders the Ventilator Inoperable
• Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to an Undersized Spring in the Controller that may Prevent the Device from Delivering the Required Pressure Levels Needed for Effective Ventilation
• Cybersecurity Vulnerabilities with Certain Patient Monitors from Contec and Epsimed: FDA Safety Communication
• Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient Results
• Copaxone, Glatopa (glatiramer acetate): Drug Safety Communication - FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis

Guidance Documents

Institutional Review Boards Frequently Asked Questions

Institutional Review Board (IRB) Written Procedures

Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Evaluation of Sex Differences in Clinical Investigations

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

Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development.

February 25, 2025; 8:30 a.m. - 5:00 p.m. ET

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) is hosting a virtual scientific public workshop on February 25, 2025, titled “Cell Therapies and Tissue-based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development.” The purpose of the workshop is to identify and discuss the current state of the science, development, and regulation for cellular therapies and tissue-based products.

Navigating Controlled Correspondences to Support Generic Drug Development

February 27, 2025; 1 - 3 p.m. ET

This event offers a comprehensive overview of controlled correspondence as an efficient pathway for communication with the FDA regarding generic drug development. FDA will host a panel discussion on topics pertinent to the generic drug industry, and answer questions during live Q&A sessions with FDA experts.

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.