February 17, 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. 13, 2026 - Outbreak Investigation of Extensively Drug-Resistant Salmonella: Moringa Powder (February 2026)
• Feb. 12, 2026 - FDA Approves Labeling Changes to Menopausal Hormone Therapy Products
• Feb. 12, 2026 - FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Oysters from British Columbia, Canada Harvest Area BC 17-20 CLF #1401656 Potentially Contaminated with Norovirus
• Feb. 12, 2026 - FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer
• Feb. 12, 2026 - FDA Finalizes Guidance on Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing Animals
• Feb. 12, 2026 - Outbreak Investigation of Listeria monocytogenes: Prepared Pasta Meals (June 2025)
• Feb. 12, 2026 - FDA Finalizes Guidance on Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing Animals
• Feb. 11, 2026 - Investigations of Foodborne Illness Outbreaks
• Feb. 11, 2026 - FDA Expert Panel on Food Allergies
• Feb. 10, 2026 - FDA Approves Pembrolizumab with Paclitaxel for Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
• Feb. 10, 2026 - FDA Launches Assessment of BHA, a Common Food Chemical Preservative

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:

• Medline Updates Instructions for Use for Homecare Beds

Consumer Updates

Hormone Replacement Therapies Can Help Women with Bothersome Menopausal Symptoms

The effects of menopause can make a woman’s daily life much harder, and therapies approved by the FDA can help.  But too many women might not use these treatments to lessen their menopause symptoms because of the risks associated with these drugs described in the drug labels’ boxed warnings (the FDA’s most prominent warnings).  The FDA has requested that drug companies remove risk statements about cardiovascular diseases, breast cancer, and probable dementia from boxed warnings for menopausal hormone therapy (MHT) – also called hormone replacement therapy (HRT).

Guidance Documents

• Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing Animals
• Certification Process for Designated Medical Gases

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.

Webinars and Virtual Workshops

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.

FDA Grand Rounds – Adeno-associated Virus-mediated Gene Therapy: Advances, Immune Challenges, and Research Innovations

Date: Thursday, Feb. 19, 2026; noon - 1 p.m. ET

This lecture will introduce gene therapy technology and examine the immunological challenges facing AAV gene therapy, including pre-existing immunity, innate and adaptive immune responses, and transgene immunogenicity.  It will highlight CBER's regulatory science research addressing these barriers through computational capsid engineering, sex-based immunological studies, and additional factors affecting product characterization and safety assessment.

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.

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers

Date: Wednesday, April 15, 2026; 1 - 2:30 p.m. ET

Join the Small Business and Industry Assistance (SBIA) program for an informative webinar on the guidance, Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers.  Expanded access is a pathway for patients with serious or immediately life-threatening diseases or conditions to gain access to investigational drugs for treatment outside of clinical trials when no comparable or satisfactory alternative treatment options are available.  The primary goal of this event is to provide attendees with a comprehensive understanding of this pathway, including the regulatory requirements and FDA’s recommendations.

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.