August 17, 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:

• Update on Alert: Convenience Kit Issue from Medline
• Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing ICU Medical Pain Management Components
• One Lot of Tyenne Injection 400 mg/20 ml Vials by Fresenius Kabi
• Breathing Circuit Set Recall: Hamilton Medical Removes Breathing Circuit Set

Updates

• Aug. 14, 2026 - Outbreak Investigation of Salmonella: Jalapeño (August 2026)
• Aug. 13, 2026 - FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and Puppies
• Aug. 13, 2026 - Investigation of Multistate Outbreak of Cyclospora Illnesses: Iceberg Lettuce (July 2026)
• Aug. 13, 2026 - FDA Grants Accelerated Approval to Iberdomide with Daratumumab and Hyaluronidase-fihj and Dexamethasone for Multiple Myeloma
• Aug. 12, 2026 - Register for RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations
• Aug. 11, 2026 - FDA Finalizes Guidance for Ready-to-Eat Fresh-Cut Produce Operations under Preventive Controls for Human Food Rule
• Aug. 10, 2026 - Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop Recordings and Presentations Available 
• Aug. 10, 2026 - Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA)

Spotlight

HHS and FDA Announce Landmark Food Policy Reforms

The U.S. Department of Health and Human Services (HHS) announced two landmark actions to modernize federal oversight of food ingredients and establish a stronger scientific foundation for future nutrition policy.  HHS proposed a rule requiring manufacturers to notify the FDA when concluding that the use of a substance added to human or animal food is Generally Recognized as Safe (GRAS) and, alongside the U.S. Department of Agriculture (USDA), submitted for final review the federal government’s first proposed definition of ultra-processed foods (UPFs).

Guidance Documents

• CVM GFI #260 - Type VII Veterinary Master File for Research and Development and Risk Reviews
• Container Closure Systems for Human Drugs and Biological Products
• Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
• Guidance for Industry: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce

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 Workshops

Public Meeting on Listeria monocytogenes Prevention

Day 1: Tuesday, Aug. 18, 2026; 9:30 a.m. – 4:30 p.m. ET
Day 2: Wednesday, Aug. 19, 2026; 9:30 a.m. – 4:30 p.m. ET

The FDA is hosting a public meeting on August 18-19, 2026, on Listeria monocytogenes prevention.  This meeting will be the first in a series of public engagements, including workshops and webinars, to discuss best practices for managing risks posed by Listeria monocytogenes (L. monocytogenes).  These discussions will highlight the perspectives of individual stakeholders and complement the agency's efforts to integrate the latest scientific advancements and emerging developments in the prevention of L. monocytogenes.

Public Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA)

Date: Wednesday, Sept. 16, 2026; 9 a.m. - 2 p.m. ET

The FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032.  The public meeting will be held at the FDA White Oak campus in Silver Spring, Maryland, with a virtual option.

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.