November 9, 2026

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 Office of Public Engagement

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 here:

• FDA Investigating Serious Risk of Malignancy Linked to Zolgensma Gene Therapy
• All Lots and Varieties of Tractor Wheels Organic Toddler Soft-Baked Bars by Once Upon A Farm: Recall - Due to Potential Choking Hazard
• Early Alert: Compact Medical Removes and Updates Use Instructions for ButterflyBVM Bag-Valve-Mask Resuscitators
• FDA Advises Consumers Not to Buy or Serve Once Upon a Farm Tractor Wheels Organic Toddler Soft-Baked Bars

Updates

• Nov. 6, 2026 - Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities: Discussion Paper and Request for Feedback
• Nov. 5, 2026 - FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma
• Nov. 4, 2026 - Outbreak Investigation of Salmonella: Sprouts (September 2026)
• Nov. 3, 2026 - FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm Infestations in Dogs and Puppies

Spotlight

FDA Provides Clarity to Support Cell and Gene Therapy Development and Quality

The FDA issued final guidance for manufacturers of cellular and gene therapy (CGT) products to implement a comprehensive, science- and risk-based plan for making sure their products meet potency standards.  The guidance provides FDA’s recommendations for a Potency Assurance Strategy, which guides manufacturers to test and verify — before a product reaches a patient — that every batch meets a defined standard of potency to do what the product is supposed to do therapeutically.

FDA Voices

By: Kyle Diamantas, J.D., Acting Commissioner of Food and Drugs

Guidance Documents

• Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus
• Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products

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.

Meetings, Conferences and Workshops

FDA and the Focused Ultrasound Foundation Co-sponsored Public Workshop: Research Roundtable on the Development of Transcranial Ultrasound for Neurological and Psychiatric Applications

Date: Tuesday, November 10, 2026; 9 a.m. - 5 p.m. ET

The FDA and the Focused Ultrasound Foundation is announcing a co-sponsored public workshop, “Research Roundtable on the Development of Transcranial Ultrasound for Neurological and Psychiatric Applications.”  The purpose of this workshop is to convene leading scientific and clinical experts to address key considerations in the rapidly evolving field of transcranial ultrasound.  By fostering collaboration among relevant stakeholders, the workshop aims to discuss approaches to safety and effectiveness that may help accelerate innovation for transcranial ultrasound device developers.  Registration closed at 4:00pm ET on November 5, 2026.

FDA Public Virtual Only Workshop: Maintenance Treatment for Ovarian Cancer Workshop: Weighing Benefit and Toxicity in an Evolving Landscape

Day 1: Thursday, November 12, 2026; at 12:30 p.m. ET
Day 2: Thursday, November 19, 2026; at 12:30 p.m. ET

New products, including antibody-drug conjugates, are being investigated as maintenance treatments for ovarian cancer, and many of these therapies are associated with substantial toxicity.  The FDA plans to host this workshop to discuss development of these new drugs.  Topics will include interpretation of PFS, use of other efficacy endpoints, importance of OS, and safety and dosing regimen considerations.

Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

ICYMI!

FDA Grand Rounds on Real-World Evidence (RWE)

Missed the recent FDA Grand Rounds on Real-World Evidence (RWE)?  The recording is now available!

About Us

The Office of Public Engagement resides within the Office of the Commissioner and falls under the Office of Public 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.