June 1, 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:

• Pediatric Care Bed Correction: KayserBetten Issues Correction for KayserBett IDA Beds
• Better Weather Fix Elixir by Better Weather Actives
• Update on Erbe USA Flexible Cryoprobes Recall
• Update to Philips’ Correction for Trilogy Evo Platform Ventilators
• Early Alert: IV Tubing Set Issue from ICU Medical
• Manifold Recall: Medline Removes Namic Star Off Handle Manifolds
• Boner Bears Chocolate by JXK Enterprises

Updates

• May 29, 2026 - European Union (EU) Mutual Recognition Agreement
• May 29, 2026 - FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
• May 28, 2026 - FDA Drug Competition Action Plan
• May 28, 2026 - FDA Approves Durvalumab in Combination with Bacillus Calmette-Guerin for High-Risk Non-Muscle Invasive Bladder Cancer
• May 28, 2026 - Microbiological Surveillance Sampling: FY26 Domestic and Imported Whole Cucumber Sampling for Salmonella
• May 28, 2026 - You’re Invited: FDA Financial Public Meeting
• May 28, 2026 - FDA Announces Updates to Modernize, Strengthen Pesticide Monitoring Compliance Program
• May 27, 2026 - Outbreak Investigation of Salmonella: Moringa Leaf Powder (May 2026)
• May 27, 2026 - FDA Approves Pivekimab Sunirine-pvzy for Blastic Plasmacytoid Dendritic Cell Neoplasm, an Ultra-Rare Hematologic Malignancy
• May 27, 2026 - FDA Releases Discussion Paper Ahead of Traceability Public Meeting in June
• May 27, 2026 - FDA Reopens Comment Period for Two Petitions Pertaining to the Use of Solvents
• May 27, 2026 - FDA Advances Post-Market Review of Phthalates Used in Food Contact Materials

FDA Voices

Fifty Years of the Medical Device Amendments: Building on a Strong Foundation to Advance Safe, Effective and High-Quality Medical Devices

By: Michelle Tarver, M.D., Ph.D., Director, Center for Devices and Radiological Health

Guidance Documents

• Q8, Q9, and Q10 Questions and Answers (R5)
• Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
• Statistical Approaches to Establishing Bioequivalence
• Content of Human Factors Information in Medical Device Marketing Submissions
• Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products

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/MHRA/Health Canada Symposium: Regulatory Perspectives in Good Clinical Practice, Bioequivalence and Good Pharmacovigilance Practice

Day 1: Monday, June 1, 2026; 8:30 a.m. - 5:15 p.m. ET
Day 2: Tuesday, June 2, 2026; 8:30 a.m. - 5 p.m. ET
Day 3: Wednesday, June 3, 2026; 8:30 a.m. - 4:50 p.m. ET

This symposium will highlight current and emerging topics of interest to the industry related to good clinical practice, bioequivalence, and good pharmacovigilance practice.  The event will bring together regulators, investigators, clinical researchers, clinical trial staff, sponsors, research organizations, service providers, pharmaceutical and biotechnology companies, academics, and patient advocacy groups.

OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products

Date: Thursday, June 4, 2026; 11 a.m. - noon ET

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), is hosting its next virtual town hall on June 4, 2026.  During this town hall, experts from OTP’s Office of Review Management & Regulatory Review (ORMRR) will answer questions regarding Biologic License Application (BLA) readiness, including how to request pre-BLA meetings, best practices for preparing submission packages, and tools to navigate the application process.

Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing

Date: Thursday, June 4, 2026; 1 - 4 p.m. ET

The FDA is announcing a public hearing to obtain feedback and perspectives regarding the CNPV Pilot Program, including feedback on the eligibility criteria, voucher selection processes, sponsor responsibilities, FDA review procedures, and program implementation.

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.