May 4, 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:

• a2 Platinum USA Label Infant Formula by A2 Milk Company
• Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods
• Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health: FDA Safety Communication
• Lactated Ringer’s Injection, 1L, E7500 by B. Braun Medical
• Early Alert: Thoracic Stent Graft Issue from Bolton Medical

Updates

• May 1, 2026 - FDA Approves Vepdegestrant for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer
• May 1, 2026 - FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
• April 30, 2026 - FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia
• April 30, 2026 - Safety Alert for Hepatitis A Virus: Concha Negra (Black Shell) Shell Meat (April 2026)
• April 30, 2026 - FDA Approves REMS for Nexplanon (etonogestrel) Implant to Reduce Complications Due to Improper Insertion and Removal
• April 30, 2026 - FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List
• April 30, 2026 - Outbreak Investigation of E. coli O157:H7: Raw Cheddar Cheese (March 2026)
• April 29, 2026 - Investigations of Foodborne Illness Outbreaks
• April 29, 2026 - FDA Releases Results from Largest-Ever Testing of Infant Formula in the U.S.
• April 29, 2026 - FDA Approves First Generic Moxidectin Oral Drench for Treatment of Internal Parasites in Sheep
• April 28, 2026 - FDA Announces Major Steps to Implement Real-Time Clinical Trials  
• April 27, 2026 - FDA Issues Emergency Use Authorization for Topical Powder to Prevent and Treat New World Screwworm in Multiple Species
• April 27, 2026 - Cosmetic Products Containing Methylene Chloride

Spotlight

C3TI Compass (Knowledge Repository)

C3TI Compass is a knowledge repository that connects users to FDA guidance documents, case studies, and resources that support innovative approaches to clinical trial design and conduct.  Compass centralizes completed activities, ongoing efforts, and practical tools to support engagement with CDER's clinical trial innovation work and improve clinical trial efficiency.

FDA Direct

The Power of Real-Time Clinical Trials

Guidance Documents

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

Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products

Day 1: Tuesday, May 5, 2026; 8:30 a.m. - 5:30 p.m. ET
Day 2: Wednesday, May 6, 2026; 8:30 a.m. - 5:30 p.m. ET

The field of generic oral drug products continues to evolve leading to innovative bioequivalence (BE) approaches when conventional in vivo bioequivalence study designs may not be feasible.  In response to these evolving complexities, this workshop is designed to address the latest advancements and regulatory challenges in the field, offering a unique platform to engage with all relevant parties, share knowledge, and contribute to the evolution of generic oral product development and regulatory assessment.

OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration

Date: Tuesday, May 5, 2026; 1 - 2 p.m. ET

The webinar provides an overview of the Over-the-Counter Drug User Fee Amendments (OMUFA) and describes the key elements of the amendments as it relates to OMUFA user fees.

FDA Oncology Center of Excellence Presents Conversations on Cancer: Oncology Nurses - Frontliners in Oncology

Date: Wednesday, May 6, 2026; 3 - 4 p.m. ET

In recognition of National Nurses Week, the FDA Oncology Center of Excellence will convene a Conversations on Cancer discussion to spotlight the critical role nurses play as frontline professionals in oncology drug development through their involvement in clinical trials, research coordination, patient care, and education.  While their responsibilities extend from direct patient interaction to significant contributions in the research and pharmaceutical industries, their expertise and contributions are often underrepresented and underrecognized in the drug development process.  This conversation opens dialogue between frontline nurses and regulatory professionals regarding their roles in cancer treatment and how nursing insights can inform oncology product development, clinical trial participation, and the patient experience.

Optimizing Pregnancy Registries Public Workshop

Day 1: Thursday, May 7, 2026; 9 a.m. - 4:15 p.m. ET
Day 2: Friday, May 8, 2026; 9 a.m. - 12:40 p.m. ET

The FDA is announcing the public workshop, "Optimizing Pregnancy Registries."  The purpose of the public workshop is to discuss challenges in designing and implementing pregnancy registries and to consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy.

Synthetic Soup: Drug Supply and Overdose Trends

Date: Thursday, May 7, 2026; 3 - 4 p.m. ET

This presentation shares laboratory findings on the rapidly changing composition of the U.S. illicit drug supply, and trends in overdose mortality.  Topics include emerging synthetic substances and notable regional variations.  Current declines in overdose deaths will be placed in both national and historical context.  The presentation emphasizes data-driven insights alongside real-world narratives to make the complexities of supply-side surveillance accessible to a broad audience.  CERSI-funded research on drug treatment and pharmacology will help connect the importance of scientific research in understanding the rapidly evolving drug environment.

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.