November 17, 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

• November 14, 2025 - FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
• November 14, 2025 - Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
• November 14, 2025 - View Recording: Initiating the Removal of the “Black Box Warning” on Hormone Replacement Therapy
• November 13, 2025 - FDA Approves First Interchangeable Biosimilar to Perjeta (pertuzumab)
• November 13, 2025 - Outbreak Investigation of Salmonella: Moringa Leaf Powder (October 2025)
• November 13, 2025 - FDA Approves Ziftomenib for Relapsed or Refractory Acute Myeloid Leukemia with a NPM1 Mutation
• November 13, 2025 - Investigations of Foodborne Illness Outbreaks
• November 12, 2025 - Africa Imports Issues Voluntary Recall of Organic Moringa Leaf Powder Due to Potential Salmonella Contamination
• November 11, 2025 - Longtime FDA Innovator Appointed as Director of Center for Drug Evaluation and Research
• November 10, 2025 - HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy
• November 9, 2025 - Get Helpful FDA Consumer Updates - Just for You
• November 7, 2025 - More Ground Cinnamon Products Added to FDA Public Health Alert Due to Presence of Elevated Levels of Lead
• November 6, 2025 - FDA Awards Second Batch of National Priority Vouchers
• November 6, 2025 - FDA Approves Daratumumab and Hyaluronidase-fihj for High-Risk Smoldering Multiple Myeloma
• November 6, 2025 - FDA Establishes Closing Date for Public Comments on MRTP Renewal Applications for IQOS Products
• November 5, 2025 - FDA Warns Companies Over Illegal Marketing of Botox and Related Products
• November 3, 2025 - FDA Issues Warning About Certain Supplements Substituted with Toxic Yellow Oleander
• October 30, 2025 - Outbreak Investigation of Listeria monocytogenes: Prepared Pasta Meals (June 2025)

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 here:

• Whole Nutrition Infant Formula 24 oz Cans and 0.6 oz Packets by ByHeart
• Three Lots of Famotidine Injection USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial by Fresenius Kabi

Consumer Updates

Microneedling Devices: Getting to the Point on Benefits, Risks and Safety

Guidance Documents

• Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
• How to Prepare a Pre-Request for Designation (Pre-RFD)

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.

FDA Direct

ICYMI!

How FDA Investigators Pinpointed Cause of Illness Tied to Nutrition Shakes at Long-Term Care Facilities

FDA food investigators Rohn Robertson and Hassan Ali got a call about an inspection earlier this year that would prove one of the most impactful of their careers.  A foodborne illness outbreak, caused by a particularly virulent strain of Listeria bacteria, was sickening older Americans living in nursing homes and other facilities across several states.

Webinars and Virtual Workshops

Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA)

Date: Fri, Dec. 3, 2025 - 9 a.m. - noon ET

The FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032.  The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological products.

Circulatory System Devices Panel Advisory Committee Meeting Announcement

Date: Fri, Dec. 3, 2025 - 9 a.m. - 6 p.m. ET

The FDA announces a forthcoming virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee (the Committee).  The general function of the Committee is to provide advice and recommendations to the Agency on the FDA’s regulatory issues.  The Committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) sponsored by V-Wave, Inc. for the V-Wave Ventura Interatrial Shunt System, which is a first-of-a-kind device permanent implant designed to shunt blood from the left to the right atrium to improve symptoms in patients with advanced chronic heart failure.  The meeting will be open to the public.  The FDA is establishing a docket for public comment.

Pediatric Developmental Safety Assessment: New Approach Methods

Date: Fri, Dec. 5, 2025 - 8 a.m. - 4 p.m. ET

The FDA in collaboration with the Triangle Center of Excellence in Regulatory Science and Innovation (Triangle CERSI) will host a public workshop entitled “Hybrid Public Workshop: Pediatric Developmental Safety Assessment and New Approach Methodologies” on December 5, 2025.  The goal of this workshop is to discuss new approach methods that can address pediatric developmental safety during drug development.

Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks

Day 1: Wed, Dec. 10, 2025; 1 - 5 p.m. ET
Day 2: Thu, Dec. 11, 2025; 8:30 a.m. - 4 p.m. ET

The aim of the public workshop is to discuss common challenges in neonatal and rare disease product development and identify opportunities to leverage rare disease product development frameworks in the neonatal product development space.

Quality and Regulatory Predictability: Shaping USP Standards

Date: Thu, Dec. 11, 2025; 9 - 10:30 a.m. ET

This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs.  Attendees will gain insights into the USP standards development process and learn how they can sponsor or participate—via public comment—in the development of future standards.

Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine

Date: Tue, Dec. 16, 2025; 9 a.m. - 4:30 p.m. ET

This one-day hybrid (virtual and in person) workshop will initiate a discussion on expanding epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality.  This public workshop is convened by FDA and the Duke-Margolis Institute for Health Policy.

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.