June 22, 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: Catheter Introducer Issue from Abiomed and Oscor
• Update: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters 
• Disruptions in Availability of Stereotactic Breast Biopsy Needles
• Early Alert: Windstone Medical Packaging, Inc. Convenience Kit Issue
• FDA Issues Warning Letter to Happiest Baby, Inc. on SNOO Products

Updates

• June 18, 2026 - Per- and Polyfluoroalkyl Substances (PFAS)
• June 18, 2026 - Questions and Answers on PFAS in Food
• June 17, 2026 - FDA Approves First Single-Dose Generic Treatment for Influenza
• June 17, 2026 - FDA Approves First Oral Carbapenem Therapy for Complicated Urinary Tract Infections
• June 17, 2026 - READI-Home Innovation Challenge Frequently Asked Questions
• June 16, 2026 - 2025 OCE Annual Report
• June 16, 2026 - Implementation for iPLEDGE REMS Modifications Delayed Until November
• June 16, 2026 - FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
• June 16, 2026 - FDA Workshop Will Focus on Development of Antihypertensive Therapies for Use in Pediatric Patients
• June 15, 2026 - Section 804 Importation Program Policies and Authorizations
• June 15, 2026 - FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes
• June 15, 2026 - Infant Formulas Marketed in the U.S.
• June 15, 2026 - Infant Formula Homepage
• June 12, 2026 - Regulatory Perspectives on Herbal Medicinal/Botanical Drug Product Development – Joint FDA/EMA Workshop

Consumer Updates

Access to Naloxone Can Save a Life During an Opioid Overdose

Naloxone products approved by the U.S. FDA are an important tool to reverse overdose in health care and community settings.  That’s one of many reasons the FDA is working to help increase access to naloxone.  For example, the FDA recently approved the third OTC naloxone nasal spray to reverse the effects of opioid overdose.

FDA Voices

Lessons Learned from our Roundtable with Rare Disease Advocates

By: Karim Mikhail, Acting Director, Center for Biologics Evaluation and Research, Mike Davis, Acting Director, Center for Drug Evaluation and Research, & Amy Comstock Rick, Director, Rare Disease Innovation Hub

There is no substitute for sitting across the table from the people we serve.  Recently we had the privilege of joining Acting Commissioner Kyle Diamantas, Acting Chief of Staff Lowell Zeta, and Deputy Commissioner Grace Graham for a roundtable discussion with 15 dedicated rare disease leaders.  Hearing directly from patients and family members who navigate these incredibly challenging conditions every day was both grounding and motivating.  The conversation reinforced our shared mission and highlighted several key areas where the U.S. Food and Drug Administration must continue to evolve to meet the unique needs of the rare disease community.

Guidance Documents

• Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug

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

Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments

Date: Tuesday, June 23, 2026; 1 - 2:30 p.m. ET

The FDA is announcing its annual public meeting and opportunity for public comment on “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments”.  This public meeting is intended to meet performance commitments included in PDUFA VII, BsUFA III, and GDUFA III.  These user fee programs were reauthorized as part of the FDA User Fee Reauthorization Act of 2022 signed by the President on September 30, 2022.

Webinar – Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge

Date: Wednesday, June 24, 2026; 1 - 2 p.m. ET

The FDA will host a webinar for industry and other interested parties to discuss the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge and answer questions about this Innovation Challenge.

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

ICYMI!

Curriculum Materials for Health Care Degree Programs | Biosimilars

FDA’s curriculum materials are intended to help educate students in health care professional degree programs, for medicine, nursing, physician assistants, and pharmacy, as well as practicing professionals, to improve understanding of biosimilar and interchangeable biosimilar products and the regulatory approval pathway in the United States.  The Resource Guide for Teaching Faculty provides information for instructors who would like to incorporate topics related to biosimilar and interchangeable biosimilar products into the education and training they provide students.  Explore FDA’s curriculum materials for health care programs.

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.