June 8, 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:

• Up & Up Fragrance Free and Fresh Cucumber Scented Baby Wipes by Target
• Early Alert: Infant Resuscitation System Issue from GE HealthCare
• Outbreak Investigation of Listeria monocytogenes: Soft Cheese (June 2026)
• Gas-X Extra Strength Softgels 125 mg, 120 ct. and 72 ct. by Haleon
• Early Alert: Insulin Pump Issue from Insulet
• Becton Dickinson Issues Correction for Certain BD Spinal Trays
• TNVitamins and Doctor’s Pride Ultra Potent Complete Green Superfood Moringa Capsules by Total Nutrition
• UPDATE: Hintermann Series H3 Total Ankle Replacement System and Long-Term Risk of Device Failure: FDA Safety Communication
• Early Alert: Catheter Introducer Kit Issue from Abiomed

Updates

• June 5, 2026 - Dear Veterinarian Letter: Use of FDA-Authorized Animal Drugs Against New World Screwworm Myiasis
• June 5, 2026 - Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing Recording Available
• June 3, 2026 - Outbreak Investigation of Salmonella: Moringa Leaf Powder (January 2026)
• June 3, 2026 - FDA Use of Real-World Evidence in Regulatory Decision-Making
• June 3, 2026 - FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury
• June 3, 2026 - Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula
• June 3, 2026 - Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
• June 2, 2026 - FDA Announces Third Annual Animal Drug User Fee Educational Conference
• June 2, 2026 - FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients

Spotlight

FDA Warns Consumers of Skin Products Containing Mercury and/or Hydroquinone

FDA advises consumers not to use over-the-counter (OTC) skin lightening products due to high levels of mercury and/or hydroquinone.  The agency also recommends consumers talk to their doctor about treatment options for certain skin conditions including aged or dark spots.  There are no FDA-approved or legally marketed OTC skin lightening products.

Guidance Documents

• Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements
• Certain Postapproval Requirements and Resources for ANDAs
• Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers
• M15 General Principles for Model-Informed Drug Development
• Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing

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

Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop

Day 1: Monday, June 8, 2026; 8:30 a.m. - 4:30 p.m. ET
Day 2: Tuesday, June 9, 2026; 8:30 a.m. - 4:30 p.m. ET

The purpose of this annual public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives.  FDA is seeking this input from the generic drug industry, academia, patient advocates, professional societies, and other interested parties, as it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs.  FDA will consider the information from the public workshop when developing its Fiscal Year (FY) 2027 Generic Drug User Fee Amendments (GDUFA) science and research priorities.

FDA Oncology Center of Excellence Presents Conversations on Cancer: Patient first = Project Facilitate June 10, 2026

Date: Wednesday, June 10, 2026; noon - 1 p.m. ET

In this session, the expert panel will explore the evolution of Project Facilitate from its inception to its current role as an essential resource for oncology providers nationwide, examining the concrete impact of Project Facilitate through data-driven insights.  They will share cases that illustrate both common scenarios and unique challenges, providing practical guidance on how to submit a single-patient IND, highlighting common pitfalls to avoid and best practices for working with pharmaceutical companies, whose agreement is required before FDA review can proceed.  Importantly, the panel will address how patient safety is maintained throughout the expanded access process, even when using investigational products whose safety and efficacy profiles are still being established.

Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations

Date: Thursday, June 11, 2026; 8:30 a.m. - 12:30 p.m. ET

This workshop is designed to facilitate discussions about the latest advancements and regulatory considerations in the evolving field of patient-centric (including pediatric) generic oral products, addressing product development and regulatory assessment challenges for these important medicines.

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.