June 15, 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:

• All Lots of Nara Infant Formula by Nara Organics
• Beekeeper’s Naturals Saline Nasal Spray Sold Through Amazon
• Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
• TNVitamins and Doctor’s Pride Ultra Potent Complete Green Superfood Moringa Capsules by Total Nutrition
• Early Alert: Positive Pressure Breathing Device Issue from Baxter
• Early Alert: Breathing Circuit Set Issue from Hamilton Medical
• Specific Lots of ChloraPrep Clear Single Sterile 1 mL and FREPP Clear 1.5 mL Applicators by BD

Updates

• June 13, 2026 - Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026)
• June 12, 2026 - FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
• June 12, 2026 - FDA Approves Capivasertib with Abiraterone and Prednisone for PTEN-deficient Androgen Pathway Modulation-naïve or -sensitive Prostate Cancer
• June 12, 2026 - Real-World Evidence Submissions to the Center for Drug Evaluation and Research
• June 12, 2026 - Real-World Evidence Submissions to the Center for Biologics Evaluation and Research
• June 12, 2026 - FDA Approves Belzutifan with Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma
• June 11, 2026 - FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats
• June 11, 2026 - FY 2027 Voluntary Qualified Importer Program (VQIP) Applications Are Open
• June 10, 2026 - FDA Releases Report on Traceability Readiness Tabletop Exercises and Updated FAQS
• June 10, 2026 - FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury

Spotlight

The U.S. FDA added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscreen innovation.  Bemotrizinol is the first new active ingredient added to the over-the-counter (OTC) sunscreen monograph since the late 1990s.

FDA Voices

Ensuring Quality and Access: FDA’s Approach to Generic Drug Oversight

By: Dr. Iilun Murphy, Director Office of Generic Drugs, Center for Drug Evaluation and Research (CDER) and Dr. Mike Kopcha, Director Office of Pharmaceutical Quality, CDER

Twenty years ago, it was uncertain whether the United States would see generic competition for complex drug products such as peptides, inhalers, and other sophisticated therapies that millions of Americans depend on.  In the past year, the U.S. Food and Drug Administration's generic drug program approved the first generic versions of complex inhalation products (Flovent, QVAR) and a glucagon-like peptide-1 (GLP-1) receptor agonist (Saxenda).  These milestones were made possible by dedicated scientific research and regulatory innovation at the FDA.  Momentum continues to build: on May 21, 2026, the FDA updated multiple product specific guidances to reduce expensive and time-consuming clinical studies needed for generic inhalation products, which could help bring more affordable options to patients sooner.  The agency continues to prioritize the speed and efficiency with which generic drugs are regulated, while balancing the need for minimizing risk and ensuring access to quality medications.

Guidance Documents

• Forms FDA 3542a and FDA 3542: Questions and Answers

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

FDA Public Meeting- Challenges and Solutions in Lot-Level Food Traceability

Date: Monday, June 15, 2026; noon - 3:30 p.m. ET

FDA is hosting a virtual public meeting on June 15, 2026, to give the public an opportunity to share information on implementation of the Food Traceability Rule and areas of remaining concern, specifically as they relate to lot-level tracking and flexibilities for compliance.

Vaccines and Related Biological Products Advisory Committee June 18, 2026 Meeting Announcement

Date: Thursday, June 18, 2026; 8:30 a.m. - 4 p.m. ET

On June 18, 2026, the Committee will meet in open session to discuss and make recommendations on the safety and effectiveness of MFLUSIVA (Influenza Vaccine, mRNA), manufactured by Moderna TX Inc., with a requested indication in Biologics License Application STN 125869/0 for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine, in persons 50 years of age and older.

View Upcoming FDA Meetings, Conferences and Workshops
Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

ICYMI!

Import Educational Resources

FDA Import Resources

This page provides videos, quick-reference guides, and a grouped index of FDA Import Program resources to assist importers, brokers, and stakeholders.

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.