February 9, 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

• Feb. 6, 2026 - FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs
• Feb. 5, 2026 - Safety Labeling Update for Capecitabine and Fluorouracil (5-FU) on Risks Associated with Dihydropyrimidine Dehydrogenase (DPD) Deficiency
• Feb. 5, 2026 - FDA Issues Emergency Use Authorization for Over-the-Counter Injectable Drug to Prevent New World Screwworm in Cattle
• Feb. 5, 2026 - FDA Takes New Approach to "No Artificial Colors" Claims
• Feb. 4, 2026 - Investigations of Foodborne Illness Outbreaks
• Feb. 3, 2026 - FDA’s Actions to Respond to Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula
• Feb. 2, 2026 - Swedish Match USA, Inc. Modified Risk Tobacco Product (MRTP) Applications for ZYN Products
• Feb. 2, 2026 - Quality Management System Regulation – Frequently Asked Questions
• Feb. 2, 2026 - FDA Rare Disease Innovation Hub

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:

• Detachable Coil System Recall: J&J MedTech/CERENOVUS Inc. Remove CEREPAK Detachable Coil System
• Glucose Monitor Sensor Recall: Abbott Diabetes Care Removes Certain FreeStyle Libre 3 and 3 Plus Sensors
• UPDATE: Risk of False Positive Lead Test Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems
• Early Alert: Heart Pump Issue from Abiomed

Guidance Documents

• E22 General Considerations for Patient Preference Studies
• Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
• Computer Software Assurance for Production and Quality Management System 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!

Biosimilar Medications — What Patients Need to Know

What are biosimilars?  Biosimilars are a type of medication used to treat a range of conditions — like chronic skin and bowel diseases, arthritis, diabetes, kidney conditions, macular degeneration, and some cancers.  A biosimilar is a type of biologic medication, and most biologic medications are made from living sources, like animal cells, bacteria, or yeast.  Because they mostly come from living sources, all types of biologics have minor differences that occur naturally between production batches.  Just like brand name drugs have generic versions, original biologics can have biosimilars.  FDA’s careful review of data, studies, and tests helps to ensure that biosimilars provide the same treatment benefits as the original FDA-approved biologic.  Biosimilars may provide you with more access to important treatments, and they may also save you money, depending on your insurance coverage.  Many different biosimilars have been approved, and more are expected.

Webinars and Virtual Workshops

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).

Town Hall – General Wellness: Policy for Low Risk Devices, Final Guidance

Date: Wednesday, Feb. 11, 2026; 1 - 2 p.m. ET

The FDA will host a town hall for industry and other interested parties to discuss updates to the General Wellness: Policy for Low Risk Devices, Final Guidance, issued on January 6, 2026.  The General Wellness: Policy for Low Risk Devices, Final Guidance provides clarity to industry and FDA staff on the Center for Devices and Radiological Health’s policy for low risk products that promote a healthy lifestyle (general wellness products).

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.

Town Hall – Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Final Guidance

Date: Wednesday, Feb. 18, 2026; 1 - 2 p.m. ET

The FDA will host a town hall for industry and other interested parties to discuss the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Final Guidance, issued on December 18, 2025.  The FDA is issuing this guidance to clarify how the FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices.  This guidance includes expanded and updated recommendations to FDA staff and sponsors considering using RWE to support a regulatory submission for medical devices.

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.

FDA/MHRA/Health Canada Symposium: Regulatory Perspectives in Good Clinical Practice, Bioequivalence and Good Pharmacovigilance Practice

Day 1: Tuesday, June 2, 2026; 8:30 am - 5:15 pm ET

Day 2: Wednesday, June 3, 2026; 8:30 am - 5:15 pm ET

Day 3: Thursday, June 4, 2026; 8:30 am - 5:15 pm ET

This symposium will highlight current and emerging topics of interest to the industry related to good clinical practice, bioequivalence, and good pharmacovigilance practice.  The event will bring together regulators, investigators, clinical researchers, clinical trial staff, sponsors, research organizations, service providers, pharmaceutical and biotechnology companies, academics, and patient advocacy groups.

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.