January 6, 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

• January 2, 2026 - 2025 FDA Achievements
• December 31, 2025 - Investigations of Foodborne Illness Outbreaks
• December 29, 2025 - FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic Products
• December 23, 2025 - Outbreak Investigation of Salmonella: Cucumbers (May 2025). Outbreak is Over. FDA Issues Warning Letter.
• December 23, 2025 - Office of the Chief Counsel - Attorney Career Opportunities

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:

• Surgical Pack Recall: Alcon Custom Pak Ophthalmic Procedure Packs
• Intravascular Administration Set Recall: ICU Medical Removes IV Gravity Burette Set
• Continuous Glucose Monitoring Software Correction: Dexcom Issues Correction for Dexcom G6 and G6 Pro Software
• Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods by Gold Star Distribution
• System Correction: IMPRIS Imaging Inc Issues Correction for IMRIS Neuro III-SV
• Endovascular Graft Recall: Cook Medical Removes Zenith Alpha 2 Thoracic Endovascular Graft
• Catheter Mount Recall: Draeger Removes ErgoStar Catheter Mounts
• Rheumacare Capsules by Handelnine Global Limited d/b/a as Navafresh
• Early Alert: Convenience Kit Needle Issue from Integra LifeSciences

Guidance Documents

• Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act

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!

Four Easy New Year’s Resolutions to Be Food Safe | FDA

At the New Year many of us think about changes to make our lives happier and healthier and resolve to carry them out.  Sometimes the changes are big and difficult, like losing 40 pounds or training for a marathon, and they turn out to be so difficult in the press of work, family responsibilities, etc., that we forget them.  But resolving to take the small, simple steps to be food safe in the New Year is neither big nor difficult and can have a major pay-off.

Webinars and Virtual Workshops

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.

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

Date: Thursday, January 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.

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, January 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, February 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.