July 21, 2025

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

Updates

• July 21, 2025 - Stanford Faculty Member George Tidmarsh, M.D., Ph.D. Named Director of Center for Drug Evaluation and Research
• July 18, 2025 - FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths
• July 17, 2025 - FDA Approves First Oral Product for Treatment and Control of Northern Fowl Mites in Laying Hens and Replacement Chickens
• July 17, 2025 - Reflections on 25 Years of Global Oncology
• July 17, 2025 - Outbreak Investigation of Salmonella: Frozen Sprouted Beans (July 2025)
• July 16, 2025 - Legislative Proposals to Maintain and Improve the Public Health Workforce, Rural Health, and Over-The-Counter Medicines
• July 16, 2025 - Outbreak Investigation of Salmonella: Pistachio Cream (June 2025)
• July 16, 2025 - FDA is Adding Pediatric Ventricular Assist Bypass (Product Code DSQ) to the Medical Device Shortage List (MDSL)
• July 16, 2025 - FDA to Revoke 52 Obsolete Standards of Identity for Food Products
• July 15, 2025 - FDA Approves First Interchangeable Rapid-Acting Insulin Medication 
• July 15, 2025 - FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
• July 14, 2025 - FDA Extends Comment Period for Proposed Method for Ranking Chemicals in Food for Post-Market Assessments
• July 14, 2025 - Food Chemical Safety
• July 14, 2025 - FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3

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:

• Continuous Ventilator (Respirator) Correction: Maquet Critical Care AB Updates Use Instructions for Servo Ventilator Systems Due to Risk of Inaccurate Compliance Measurement Leading to Improper Tidal Volume Delivery in Neonatal Patients
• Applicator Recall: Integra LifeSciences Removes MicroMyst Applicators Due to Potential Sterility Concerns
• SunMed Holdings, LLC Removes Adult Manual Resuscitator Devices Due to Incorrect Assembly of B/V Filter
• Sucralfate Tablets USP, 1 Gram by Nostrum Laboratories
• Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly
• Dexcom Recalls Certain Glucose Monitor Receivers for Missing Blood Sugar Level Alerts
• Drive DeVilbiss Healthcare Removes iGo DV6X-619 DC Car Adapter
• One Additional Lot of Cefazolin for Injection by Sandoz
• Early Alert: Microbore Extension Set Issue from B. Braun Medical Inc
• Early Alert: Infusion Set Performance Issue from BD

Guidance Documents

• Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry
• E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials
• Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs’ Effects
• Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen

FDA Direct

From Menopause to Food Safety: FDA's Latest Regulatory Priorities

ICYMI!

Food and Water Safety During Power Outages and Floods

Emergencies can happen, especially with extreme weather conditions.  When they do, the best strategy is to already have a plan in place.  This includes knowing the proper food safety precautions to take before, during, and after a power outage — and being prepared to safely handle food and water in the event that flooding occurs.

Webinars and Virtual Workshops

FDA Grand Rounds – Forensic Proteomics Applied to FDA-Regulated Products

Date: Thu, July 31, 2025; noon - 1 p.m. ET

Proteins and peptides are being increasingly used in therapeutic formulations.  This presentation will discuss the techniques utilized at the National Forensic Chemistry Center to analyze proteins and peptides in FDA-regulated products.

Register for the FDA’s Public Meeting on the Reauthorization of the Medical Device User Fee Amendments

Date: Mon, Aug. 4, 2025; 10 a.m. - 3 p.m. ET

The FDA is announcing a public meeting on the reauthorization of the Medical Device User Fee Amendments for fiscal years 2028 through 2032 (MDUFA VI).

Compounding Quality Center of Excellence | Annual Conference

Day1: Mon, Aug. 25, 2025; 2 - 5 p.m. ET
Day 2: Wed, Aug. 27, 2025; 9 a.m. - 6 p.m. ET
Day 3: Thu, Aug. 28, 2025; 9 a.m. - 4:30 p.m. ET

FDA’s Compounding Quality Center of Excellence will host its sixth Annual Conference.  Participants can attend this free, hybrid conference in person at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland, or virtually.  The conference will convene outsourcing facilities, pharmacy compounders and others from across the industry to discuss emerging trends and best practices through presentations, panels and interactive sessions.

Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act

Date: Mon, Sept. 15, 2025; 9 a.m. - 4:30 p.m. ET

The purpose of the public meeting is to seek input from interested parties including, patient/parent/caregiver groups, consumer groups, regulated industry, academia, and others.  This input will enable FDA to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, including pediatric drug and biologic development and labeling, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA).

FDA Public Meeting: BsUFA III Regulatory Science Program Interim Public Meeting

Date: Thu, Sept. 18, 2025; 9 a.m. - 3 p.m. ET

The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual meeting on September 18, 2025, to meet the BsUFA III Commitment to review the progress of the pilot program’s aims, or demonstration projects, and solicit input on future priorities.  The meeting agenda includes an overview of the regulatory science program, presentations by internal and external awardees conducting research projects under the BsUFA III regulatory science program, and panel discussions by FDA staff and representatives from the biosimilar industry.

FDA Public Workshop: Future Needs for the Development of Interchangeable Products

Date: Fri, Sept. 19, 2025; 9 a.m. - 1 p.m. ET

The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual public workshop on September 19, 2025, to meet the BsUFA III commitment.  The meeting agenda includes presentations by representatives from the biosimilar industry on the future needs for the development of interchangeable products, discussions on specific interchangeable topics, and a panel discussion with industry.

FDA/The Osteosarcoma Institute (OSI) Workshop: Advancing Osteosarcoma Drug Development – Connecting Research and Regulatory Pathways for Improved Outcomes

Date: Fri, Oct. 10, 2025; 9:30 a.m. - 5 p.m. ET

The FDA Oncology Center of Excellence (OCE) and The Osteosarcoma Institute (OSI) have a shared interest in engaging with the osteosarcoma community to identify the major barriers to drug development for osteosarcoma and to discuss opportunities for collaboration to address these challenges.

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.