January 20, 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. 16, 2026 - FDA Grants Full Approval of First Oral Treatment for Lymphoma in Dogs
• Jan. 15, 2026 - Outbreak Investigation of Salmonella: Dietary Supplement (January 2026)
• Jan. 15, 2026 - Office of New Drugs Custom Medical Queries (OCMQs)
• Jan. 14, 2026 - Investigations of Foodborne Illness Outbreaks
• Jan. 14, 2026 - Guiding Principles of Good AI Practice in Drug Development
• Jan. 13, 2026 - FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medications
• Jan. 13, 2026 - FDA Announces Australia Certificate Requirements for Bivalve Molluscs and Bivalve Mollusc Products Imported into Australia
• Jan. 12, 2026 - FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials
• Jan. 12, 2026 - FDA Approves First Treatment for Children with Menkes Disease
• Jan. 12, 2026 - FDA's Rare Disease Day 2026 - Agenda Now Available
• Jan. 11, 2026 - FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

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:

• Early Alert: Stent and Electrocautery-Enhanced Delivery System Issue from Boston Scientific
• Early Alert: Broselow Rainbow Tape Issue from AirLife
• Anesthetic Vaporizer Recall: Draeger Removes Certain Vapor 2000 and Vapor 3000 Vaporizers
• Anesthesia Kit Recall: Medline Removes Anesthesia Circuits and Anesthesia Circuit Kits
• Early Alert: Dialysis Tubing Set Issue from Vantive

Consumer Updates

My Dog Has Cancer: What Do I Need to Know?

Any pet owner who has been told their animal has cancer knows the two emotions: anxiety for the beloved pet’s life, and hope for an effective treatment.  “Many people consider their dogs and cats members of the family,” says Food and Drug Administration veterinarian Lisa Troutman.  “Just as the FDA reviews drugs for humans for safety and effectiveness before they can go on the market, the agency does the same for treatments for animals.”  Take, for instance, cancer, which accounts for almost half of the deaths of pets over 10 years of age.  Although pets of any age can have cancer, the longer they live, the greater the likelihood of developing it.  Dogs get cancer at roughly the same rate as humans.

Guidance Documents

• Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

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!

College Women's Health

FDA Office of Women's Health (OWH) has tips and resources that every college woman can use on topics like medication safety, nutrition, cosmetics, reproductive health, and more.  Whether you are a campus leader, college health professional, or parent, use the resources on this webpage to connect young women to FDA health and safety resources.

Webinars and Virtual Workshops

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.

FDA Grand Rounds – Antibody Glycosylation Insights for High-Quality Biotherapeutics

Date: Thursday, Jan. 22, 2026; noon - 1 p.m. ET

This lecture will examine how antibody Fc glycosylation influences product quality, potency, and clinical performance, highlighting common glycan features in FDA-approved antibodies, strategies for glycosylation control, and the use of a tailored lectin microarray for characterization.  It will also address the gap between in vitro Fc-mediated effector functions and clinical evidence, emphasizing a mechanism-driven, totality-of-evidence approach to quality and regulatory assessment.

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.

Eco-NAMs Webinar Series | Gill Cell-Line Assay for Acute Fish Toxicity Prediction

Date: Wednesday, Jan. 28, 2026; 8 - 9:30 a.m. ET

The Eco-NAMS webinar series is co-organized by the FDA, U.S. Environmental Protection Agency, European Medicines Agency, Health and Environmental Sciences Institute, National Institute for Environmental Studies (Japan), and PETA Science Consortium International e.V.  The series aims to offer the most informative and up-to-date science on the use of new approach methodologies (NAMs) for ecotoxicity assessments (Eco-NAMs) and provides an open forum for scientists from academia, industry, non-government organizations, regulatory authorities, and other interested parties, including the general public, to learn about and discuss various ecotoxicity NAMs topics.

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.