NYSDA Publications

FDA Issues Regulatory Update

Dec 15, 2025

December 15, 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

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:

Guidance Documents

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

Commissioner Makary and other members of FDA leadership, as well as guests, engage in timely and frank discussions to bring you an inside look at the current happenings at the FDA.

ICYMI!

Keep Your Dogs and Cats Safe from Holiday Hazards

Happy holidays?  Not if your pet gets sick.  The FDA Center for Veterinary Medicine (CVM) discusses some unhealthy holiday temptations and how to keep your pets safe.

Webinars and Virtual Workshops

Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine

Date: Tuesday, December 16, 2025; 9 a.m. - 4:30 p.m. ET

This hybrid public workshop will initiate a discussion on expanding epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality.

Webinar - Quality Management System Regulation: Key Takeaways

Date: Tuesday, December 16, 2025; 1 - 2 p.m. ET

The FDA will host a webinar for industry and other interested parties to discuss the Quality Management System Regulation (QMSR).  The FDA will highlight key takeaways of the QMSR and address frequently asked questions regarding this topic.

FDA and The American Society of Pediatric Hematology/Oncology (ASPHO) Pediatric Hematology/Oncology Educational Program

Date: Application Deadline Monday, Dec. 29, 2025, 3 p.m. CT

The FDA and ASPHO have partnered to cosponsor an 8-month interactive educational program designed for early career pediatric hematology/oncology clinicians and researchers.  This program addresses a critical gap in training by providing learners with a foundational understanding of pediatric hematology/oncology drug-development and the regulatory review process.

Cheminformatics Resources of U.S. Governmental Organizations 2026 Workshop

Day 1: Monday, Jan. 5, 2026; 9 a.m. - 4:30 p.m. ET
Day 2: Tuesday, Jan. 6, 2026; 9 a.m. - 4:30 p.m. ET
Day 3: Wednesday, Jan. 7, 2026; 9 a.m. - 4:30 p.m. ET

The purpose of the Cheminformatics Resources of U.S. Governmental Organizations 2026 Workshop is to enhance communication and collaboration between the U.S. Government-funded organizations that create and maintain databases, data standards, datasets, scientific approaches and computational resources dealing with chemical structures and properties of molecules and materials.

Tobacco Products Scientific Advisory Committee Meeting

Date: Thursday, Jan. 22, 2026; 9 a.m. - 4:30 p.m. ET

Center for Tobacco Products’ TPSAC will meet virtually for an open session, during which the Committee will discuss modified risk tobacco product applications submitted by Swedish Match USA, Inc. for the following products, each available in two strengths (3 milligrams and 6 milligrams).  Discussion will focus on evidence related to the relative health risks of the products, consumer understanding and perceptions of the applicant’s proposed modified risk claim, and the potential public health impact of a modified risk marketing order.

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

Day 1: Thursday, Feb. 5, 2026; 1:30 - 5 p.m. ET
Day 2: Friday, Feb. 6, 2026; 8:30 a.m. - 4 p.m. ET

The FDA, in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI), is announcing the following public workshop titled "Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks."  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.

Virtual Public Meeting and Listening Session on Food Allergen Thresholds and Their Potential Applications

Day 1: Wednesday, Feb. 18, 2026; 10:45 a.m. - 4 p.m. ET
Day 2: Thursday, Feb. 19, 2026; 10 - 11:30 a.m. ET and 2 - 3:30 p.m. ET
Day 3: Friday, Feb. 20, 2026; 10 - 11:30 a.m. ET and 2 - 3:30 p.m. ET

The FDA has rescheduled the virtual public meeting on food allergen thresholds and their potential applications in the United States to February 18, 2026, and the listening sessions to February 19-20, 2026.  The FDA will host these events in collaboration with various stakeholders, including industry, consumer groups, healthcare professionals, individual firms, retailers, and academic researchers.  These collaborative efforts will help inform the FDA's next steps, prioritize potential options, and advance our food allergen threshold approaches to benefit public health.

Public Meeting: FDA Rare Disease Day 2026

Date: Monday, Feb. 23, 2026; 9 a.m. - 4 p.m. ET

FDA will host Rare Disease Day, a virtual public meeting, on Monday, February 23, 2026 in global observance of Rare Disease Week.  The theme is: “Moving Forward. Looking Ahead. An Event for Patients.”  The goal of this year’s Rare Disease Day is to explore ways to engage and collaborate with patients and their communities to support and accelerate the development of medical products for rare diseases.  We want patients to connect with FDA and stay involved with our outreach and engagement programs to ensure the patient voice informs medical product development and regulation throughout FDA.

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.