May 26, 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:

• Early Alert: Heart Pump Controller Issue from Abiomed
• Ventilator Recall: React Health Removes VOCSN V+Pro Ventilators
• WAP Sensual Enhancement Capsules by Best Supplements Best Prices
• Early Alert: Anesthesia Machine Issue from Draeger, Inc.

Updates

• May 22, 2026 - FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
• May 22, 2026 - FDA has Approved a New Over the Counter (OTC) Option for People with Acne
• May 22, 2026 - FDA Opens First FY2027 Grant Funding Application Period for Animal Drugs for Minor Uses and Minor Species
• May 22, 2026 - FDA Approves Datopotamab Deruxtecan-dlnk for Unresectable or Metastatic Triple-Negative Breast Cancer
• May 21, 2026 - FDA Announces Availability of Industry Training on the Food Traceability Rule  
• May 21, 2026 - FDA Publishes Final Guidance on Protein Quality Studies for Infant Formula
• May 21, 2026 - The FDA Oncology Center of Excellence (OCE) has Announced a Request for Applications for Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers 
• May 20, 2026 - FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products
• May 19, 2026 - FDA Issues Emergency Use Authorization for Over-the-Counter Injectable Drug for New World Screwworm in Dairy Cattle, Horses, Swine, Sheep, and Deer
• May 15, 2026 - FDA Approves Two Separate Indications for Fam-trastuzumab Deruxtecan-nxki in HER2-Positive Early-Stage Breast Cancer

Spotlight

Product-Specific Guidances for Generic Drug Development

FDA published 71 product-specific guidances (PSGs), including 54 for products with no approved generics, 32 for complex drug products, and 23 new PSGs.  This batch includes new or revised PSGs for medications that treat diseases and conditions such as opioid use disorder, hypoparathyroidism, and the treatment of myelodysplastic syndromes, among others.

Guidance Documents

• M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)
• Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein
• Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

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

Animal Generic Drug User Fee Act Virtual Public Meeting

Date: Wednesday, May 27, 2026; 11 a.m. - 1 p.m. ET

The purpose of the public meeting is to invite public comment on the AGDUFA program and suggestions regarding the features FDA should consider for the next reauthorization of the AGDUFA program.

Animal Drug User Fee Act Virtual Public Meeting

Date: Wednesday, May 27, 2026; 2 - 4 p.m. ET

The purpose of the public meeting is to invite public comments on the ADUFA program and suggestions regarding the features FDA should consider for the next reauthorization of the ADUFA program.

Eco-NAMs Webinar Series | In Silico Approaches to Replace Acute Fish Toxicity

Date: Thursday, May 28, 2026; 8 - 9 a.m. ET

The series' third webinar, In silico approaches to replace acute fish toxicity, will feature presentations by Anna Lombardo, researcher at Istituto di Ricerche Farmacologiche “Mario Negri” and Paul Thomas, President, Model Developer and Expert Ecotoxicologist at KREATiS.

Vaccines and Related Biological Products Advisory Committee May 28, 2026 Meeting Announcement

Date: Thursday, May 28, 2026; 8:30 a.m. - 4:30 p.m. ET

On May 28, 2026, the Committee will meet in open session to discuss and make recommendations on the selection of the 2026-2027 Formula for COVID-19 vaccines for use in the United States.

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

ICYMI!

Clinical Trials Day

We celebrate Clinical Trials Day on May 20, in recognition of what is often considered the start of the first randomized clinical trial.  In 1747, James Lind began a clinical trial on this day to study the effects of different remedies for scurvy among sailors at sea.  His research famously provided evidence of the benefits of citrus fruits to treat this disease.  Clinical trials have undergone many changes since the time of James Lind, not only in respect to medical, scientific, and technological advances, but also in terms of ethical and legal requirements.  Regardless, clinical trials remain a critical part of drug development, as a means of generating evidence to support the regulatory decision-making for safe and effective new medicines.

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.