January 12, 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

Updates

• Jan. 11, 2026 - FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation
• Jan. 9, 2026 - FDA Approves First Generic Robenacoxib Tablet for Postoperative Pain & Inflammation in Cats
• Jan. 9, 2026 - FDA Approves First Generic Drug for Control of Clinical Signs of Equine Cushing’s Disease
• Jan. 8, 2026 - Request for Patient and Consumer Advocacy Group Participation in BsUFA Reauthorization Stakeholder Consultation Meetings
• Jan. 7, 2026 - Investigations of Foodborne Illness Outbreaks
• Jan. 5, 2026 - Happy New Year!

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:

• “Modern Warrior Ready” Dietary Supplement by Modern Warrior
• Silintan Capsules by Anthony Trinh, 123Herbals (123HERBALS.COM)
• Organ Recovery Pack Correction: AVID Medical Issues Correction for Medical Convenience and Organ Recovery Kits

Guidance Documents

• General Wellness: Policy for Low Risk Devices
• Clinical Decision Support Software

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!

FDA 101: Product Recalls

A recall is an action taken by a company to correct or remove from the market an FDA regulated product that violates U.S. laws and regulations.  Recalls may be initiated voluntarily by a company, or at the request of the FDA.  Recalls are important because they protect the public from products that may cause injury, illness or even death.  More than 83,000 FDA regulated products were recalled between 2014 and 2024.  Most recalls involve removing violative FDA regulated products from the market, but there are instances where a violation can be corrected without removing the products from distribution.

Webinars and Virtual Workshops

Town Hall – Quality Management System Regulation: Risk and Design and Development

Date: Wednesday, Jan. 14, 2026; 2 - 3 p.m. ET

The FDA will host a town hall for industry and other interested parties to discuss the Quality Management System Regulation (QMSR).  The FDA will discuss how the QMSR addresses risk management, risk-based approach, risk-based decisions, and design and development and will address frequently asked questions regarding these topics.

FDA Grand Rounds – Statistical Considerations for Drug Development in Rare Disease

Date: Thursday, Jan. 15, 2026; noon - 1 p.m. ET

The first portion of this talk will focus on introducing some of the key challenges of designing a phase 3 trial in a rare disease setting and the ways statistics may be used to inform design decisions, and the second portion of the talk will focus on the ways adaptive design may be used to address the lack of information often faced at the design phase.

2026 FDA Broad Agency Announcement Day

Date: Tuesday, Jan. 20, 2026; 1 - 4 p.m. ET

FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation.  2026 FDA BAA Day will provide an opportunity to the applicants as well as FDA staff to learn more about the application process and FDA’s priorities for regulatory science research.  Join us to learn more about the research priorities for Fiscal Year 2026 BAA, and how to apply.

FDA Information Session on Generic Drug Research Needs & Opportunities for FY 2026

Date: Wednesday, Jan. 21, 2026; 1 - 2:30 p.m. ET

The FDA is hosting a virtual Information Session on Generic Drug Research Needs & Opportunities for fiscal year (FY) 2026.  The goal of this session is to engage researchers in academia and other research organizations who may be interested in developing research proposals that align with the FDA’s GDUFA Science and Research Priority Initiatives for FY 2026.  During the information session, FDA scientists will describe FY 2026 research needs and opportunities in selected GDUFA priority areas, explaining how specific research would accelerate and expand patient access to high-quality, safe, and effective generic medicines.

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.

Labeling for Transparency and Trust in Artificial Intelligence (AI) and Machine Learning (ML) Enabled Cardiac Devices and Software: Patient and Clinician Needs

Date: Tuesday, Jan. 27, 2026; 3 - 4 p.m. ET

Artificial intelligence (AI) and machine learning (ML) are increasingly embedded in cardiac monitoring and diagnostic devices, yet adoption depends on transparency and merited trust among clinicians and patients.  This research explored what information users need to trust and accept AI/ML-enabled technologies in cardiology.

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.

Roundtable on Premarket Tobacco Product Application (PMTA) Submissions for Electronic Nicotine Delivery Systems (ENDS) Products

Date: Tuesday, Feb. 10, 2026; 9 a.m. - 5 p.m. ET

The purpose of the roundtable is to provide small tobacco product manufacturers (fewer than 350 employees) an opportunity to share their experiences and perspectives on the PMTA process and to offer feedback on how FDA can improve efficiency and streamline PMTA reviews.  The topics to be discussed will include certain components of PMTAs such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk).

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.

FDA Expert Panel on Food Allergies

Date: Wednesday, Feb. 25, 2026; 1 - 3 p.m. ET

The FDA Expert Panels are roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and may offer recommendations for regulatory action.  This initiative is part of the FDA’s broader efforts to apply rigorous, evidence-based standards to modernize regulatory oversight, while considering evolving science and consumer health.  The FDA Expert Panel on Food Allergies will facilitate discussions on the etiology and best treatments for food allergies as well as current health guidelines.

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.