October 19, 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:

• Early Alert: Transcatheter Mitral Valve Delivery System Issue
• Argatroban Injection by Par Health: Recall - Due to the Presence of Particulate Matter
• Two Lots of Brevital Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) by Par Health

Updates

• Oct. 16, 2026 - FDA Approves New Nonprescription Eye Drop for Relief of Eye Redness
• Oct. 16, 2026 - Counterfeit Versions of Eye Drops Found in Several States
• Oct. 14, 2026 - FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer 
• Oct. 13, 2026 - Primary Care Providers Can Prescribe with Confidence
• Oct. 9, 2026 - FDA Approves Drug to Treat Lesions Caused by Herpes Simplex Virus

Spotlight

FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development

Guidance Documents

• Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements
• Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy

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 Grand Rounds – Real-World Evidence Series: Center for Devices and Radiological Health RWE Program and Recent RWE Examples

Date: Thursday, October 22, 2026; noon - 1 p.m. ET

This session will highlight the Real-World Evidence (RWE) Program at the FDA’s Center for Devices and Radiological Health (CDRH), with a focus on recent RWE examples in the digital health technology space.  Through presentations and panel discussion with CDRH experts, participants will gain practical insight into CDRH's RWE Program and explore how these principles could support evidence generation.

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

ICYMI!

Biosimilars Basics for Patients

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.