August 10, 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:

• Certain Lots of Compounded Glutathione 200 mg/mL Multi-Dose Vials by Victory Medical Center Pharmacy
• Early Alert: Intraosseous Needle Set Issue from Becton Dickinson
• OPTIRAY Imaging Bulk Package - 350, 500mL, Vial by Liebel-Flarsheim Company
• Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injection

Updates

• Aug. 7, 2026 - FDA Issues Emergency Use Authorization for Drug to Prevent New World Screwworm in Multiple Species, Including Sheep, Cattle, Goats, and Swine
• Aug. 6, 2026 - FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma 
• Aug. 6, 2026 - FDA and NOAA Update Certification Procedures for Seafood Exported to the European Union
• Aug. 6, 2026 - Outbreak Investigation of Salmonella: Jalapeño (August 2026)
• Aug. 5, 2026 - FDA Finalizes Guidance on Evaluating Safety of Antimicrobial Animal Drugs Based on Their Importance in Human Medicine
• Aug. 4, 2026 - FDA Webinar Recording Available - Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing
• Aug. 4, 2026 - Pilot Program Update: FDA Authorizes 4 New Nicotine Pouches
• Aug. 3, 2026 - FDA Releases Additional Information ahead of Listeria Prevention Public Meeting

Spotlight

FDA Approves First Drug to Treat the Full Range of Narcolepsy Type 1 Symptoms

The U.S. FDA approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults.  Orzeyful is the first medicine approved for narcolepsy type 1 as a complete disorder — addressing the full range of symptoms that define the condition — and the first to work by directly targeting the loss of orexin signaling that causes the disease.

FDA Voices

Investing in FDA’s Inspectional Enterprise

By: Elizabeth Miller, PharmD, Associate Commissioner for Inspections and Investigations and Lowell Zeta, JD, Acting Chief of Staff and Deputy Commissioner for Strategic Initiatives

At the U.S. FDA, transparency with our stakeholders is essential to our mission.  Patients, healthcare providers, and industry rely on a regulatory system that is rigorous, but also predictable, understandable, and accountable.  As part of the FDA’s broader transparency efforts, we are taking steps to modernize how we communicate, how we make decisions, and how we carry out regulatory responsibilities.  A critical component of that effort is the transformation of our inspectional enterprise, including how we plan, coordinate, and execute inspections across the agency.

America Must Address Early Clinical Development

By: Karim Mikhail, B. Pharm, MSc, Acting Director of the Center for Biologics Evaluation and Research

Guidance Documents

• CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern
• Applying Human Factors and Usability Engineering to Medical Devices

Webinars and Virtual Workshops

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.