July 20, 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 Public Engagement Staff
Public Engagement Staff | FDA

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:

• Iceberg Lettuce from Central Mexico by Taylor Fresh Foods
• Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
• Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and Saline and Lidocaine
• Convenience Kit Recall: Certain B. Braun Spinal Anesthesia Kits
• Early Alert: Ventilator Issue from Resmed
• Pulmonary Valve Catheter Delivery System Removal from Medtronic

Updates

• July 19, 2026 - Investigation of 5-State Outbreak of Cyclospora Illnesses: Iceberg Lettuce (July 2026)
• July 17, 2026 - FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
• July 17, 2026 - Secretary Kennedy Announces Major Update to 63-Year-Old Orange Juice Regulation
• July 15, 2026 - FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses
• July 14, 2026 - FDA Approves First Generics of Gilotrif (afatinib) Tablets
• July 14, 2026 - FDA Approves Gedatolisib with Fulvestrant, with or without Palbociclib, for HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
• July 14, 2026 - FDA Grants Traditional Approval to Selpercatinib for Locally Advanced or Metastatic RET Fusion-Positive Solid Tumors
• July 14, 2026 - FDA Requests Input on Certain Non-Device Software Functions and Impacts to Patient Safety
• July 14, 2026 - Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens
• July 13, 2026 - FDA Approves First At-home Starting Dose for Alzheimer’s Disease Treatment
• July 13, 2026 - Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula
• July 13, 2026 - FDA Calls on Infant Formula Industry to Better Safeguard Against Contaminants Introduced through their Supply Chain

Spotlight

Psychedelic Drugs

FDA is supporting the development of psychedelic drugs, including new treatments for serious mental health conditions.

In recent years, there has been growing interest in and active research on the therapeutic potential of psychedelic drugs, in particular for the treatment of serious mental health conditions.  In response, FDA has made significant advances in psychedelic drug development through the issuance of scientific guidance, engagement with federal partners and the public, and regulatory actions to support drug development.

Consumer Updates

Cyclospora and Your Food: What You Should Know

FDA Voices

An Enduring Mission in a New Era: The FDA Public Health Pillars

By: Kyle A. Diamantas, J.D., Acting Commissioner of Food and Drugs and the U.S. Food and Drug Administration Executive Team

Guidance Documents

• Now Available: New recorded webinar on FDA’s recently published guidance, Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application (BLA)
• Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs
• Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
• Psychedelic Drugs: Considerations for 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

Town Hall – Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance

Date: Wednesday, July 22, 2026; 1 - 2 p.m. ET

The U.S. FDA will host a town hall for industry and other interested parties to discuss the final guidance titled Content of Human Factors Information in Medical Device Marketing Submissions, issued on May 29, 2026.

FDA Grand Rounds – Role of FDA in Preventing Medication Errors

Date: Thursday, July 23, 2026; noon - 1 p.m. ET

This lecture will present strategies to identify and prevent medication errors in the pre-marketing and postmarketing spaces.

Meeting of the Pharmacy Compounding Advisory Committee

Day 1: Thursday, July 23, 2026; 8 a.m. - 3:50 p.m. ET
Day 2: Friday, July 24, 2026; 8 a.m. - 3:50 p.m. ET

On July 23, 2026, the Committee will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: BPC-157-related bulk drug substances (BPC-157 (free base)/ BPC-157 acetate), KPV-related bulk drug substances (KPV (free base)/ KPV acetate), TB-500-related bulk drug substances (TB-500 (free base)/ TB-500 acetate), and MOTs-C-related bulk drug substances (MOTs-C (free base)/ MOTs-C acetate).  On July 24, 2026, the Committee will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: Emideltide (also referred to as delta sleeping inducing peptide (DSIP))-related bulk drug substances (Emideltide (free base)/ Emideltide acetate), Semax-related bulk drug substances (Semax (free base)/ Semax acetate), and Epitalon-related bulk drug substances (Epitalon (free base)/ Epitalon acetate).

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.