The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders.  You can read the FDA regulatory update for stakeholders below.

June 16, 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

• June 13, 2025 - Outbreak Investigation of Salmonella: Pistachio Cream (June 2025)
• June 13, 2025 - OCP 2024 Annual Report
• June 13, 2025 - FDA Approves Neoadjuvant and Adjuvant Pembrolizumab for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
• June 12, 2025 - FDA Approves Mitomycin Intravesical Solution for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
• June 11, 2025 - FDA Releases Educational Materials on the New Dietary Ingredient Notification Process for Dietary Supplements
• June 11, 2025 - FDA Approves Taletrectinib for ROS1-Positive Non-Small Cell Lung Cancer
• June 11, 2025 - New Dietary Ingredient (NDI) Notification Process
• June 10, 2025 - Don’t be Influenced (PSA)
• June 9, 2025 - Model Master Files: Advancing Modeling/Simulation in Generic Drug Development/Regulatory Submissions
• June 9, 2025 - FDA Approves Enflonsia (Clesrovimab), a Single-Dose Monoclonal Antibody Indicated to Prevent Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Neonates and Infants Born During or Entering Their First RSV Season

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:

• Class I Recall Notice: Intra-Operative Positioning System Guidewire Issue from Centerline Biomedical
• Liquid Bicarbonate Concentrate Recall: Nipro Removes MedicaLyte Liquid Bicarbonate Concentrate Due to Contamination
• Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs by Church & Dwight Co.: Recall - Due to Microbial Contamination
• Outbreak Investigation of Salmonella: Eggs (June 2025)

FDA Direct

Guidance Documents

• ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions

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.

ICYMI!

Hurricane Season: Be Prepared

When gale-force winds start blowing and torrential rains raise water levels, you need to be ready.  Power outages mean refrigerated food and medicine supplies may spoil.  Floods may contaminate tap water and emergency supplies not stored properly with sewage, chemicals, heavy metals, pathogenic microorganisms, or other contaminants.  If the storm or flood is severe enough, you may need to evacuate with little time to prepare.  Don’t put off being prepared until the emergency hits.

Webinars and Virtual Workshops

Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA)

Date: Fri, July 11, 2025; 9 a.m. - 2 p.m. ET

The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 through 2032.

Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA)

Date: Mon, July 14, 2025; 9 a.m. - 2 p.m. ET

The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032.

CVM Public Meeting: Second Annual Animal Drug User Fee Educational Conference

Date: Tue, July 15, 2025; 9 a.m. - 5 p.m. ET

FDA’s Center for Veterinary Medicine (CVM) will host the second meeting in a series of five public meetings to provide educational sessions for stakeholders who are interested in the new animal drug approval process.

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

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

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

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

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

The U.S. Food and Drug Administration (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.