February 23, 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. 20, 2026 - FDA Approves Acalabrutinib with Venetoclax for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
• Feb. 19, 2026 - Outbreak Investigation of Extensively Drug-Resistant Salmonella: Moringa Powder (February 2026)
• Feb. 19, 2026 - FDA Takes Several Actions Related to the Food Traceability Rule
• Feb. 19, 2026 - FDA Rare Disease Day Virtual Meeting – February 23 Streaming Link Available
• Feb. 19, 2026 - Investigations of Foodborne Illness Outbreaks
• Feb. 18, 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. 18, 2026 - FDA Issues Emergency Use Authorizations for Drugs to Treat New World Screwworm in Dogs and Cats
• Feb. 17, 2026 - Registration Open for RISE Together: Data Sharing Across the Rare Disease Ecosystem

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:

• Alkaloids Chewable Tablets—White Vein by Shaman Botanicals
• Early Alert: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems
• Outbreak Investigation of Extensively Drug-Resistant Salmonella: Moringa Powder (February 2026)

Guidance Documents

• Questions and Answers About Requirements for Additional Traceability Records for Certain Foods

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!

Cosmetics Direct

Cosmetics Direct is an electronic submissions portal for the registration & listing of cosmetic product facilities and products.  It is an FDA Structured Product Labeling (SPL) authoring tool, for cosmetic product facility registration and cosmetic product listing, that contains user friendly data entry forms, performs initial validations, creates and saves the SPL submission, and submits the SPL to FDA for internal processing without having to use the Electronic Submissions Gateway Next Generation (ESG NextGen).

Webinars and Virtual Workshops

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.

Town Hall – Clinical Decision Support Software, Final Guidance

Date: Wednesday, March 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 Clinical Decision Support Software, Final Guidance, issued on January 6, 2026, and re-issued on January 29, 2026.

RISE Together: Data Sharing Across the Rare Disease Ecosystem

Date: Monday, March 30, 2026; 9 a.m. - 4:30 p.m. ET

This public workshop, co-convened by the Duke-Margolis Institute for Health Policy and the FDA Rare Disease Innovation Hub, is designed for all stakeholders in the rare disease community to explore data sharing as it pertains to informing development and regulatory review for rare disease therapies.  The workshop will focus on clarifying possible avenues for data sharing and the types of data that can be shared (e.g., safety information, real-world evidence, and deidentified patient data).  The workshop will also discuss: the promotion of data sharing practices and structures for facilitating data sharing among rare disease drug development stakeholders; examples of the impact of data sharing in regulatory submissions; a priori considerations for the collection and sharing of high quality data; some of the logistical and legal challenges encountered in data sharing; and whether there are ways that FDA might support data sharing, within the bounds of its authority.

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.

Achieving Data Quality and Integrity in Maximum Containment Laboratories — Nonclinical Course (FDA-UTMB Collaborative Education Program)

Day 1: Monday, April 20, 2026; 8:15 a.m. to 4:30 p.m. CDT
Day 2: Tuesday, April 21, 2026; 8:15 a.m. – 4:30 p.m. CDT
Day 3: Wednesday, April 22, 2026; 8:15 am – 4:30 pm CDT
Day 4: Thursday, April 23, 2026; 8:15 a.m. to 4:30 p.m. CDT
Day 5: Friday, April 24, 2026; 8:15 a.m. – 12:15 p.m. CDT

The four and one-half day training program is offered annually utilizing expert faculty from the FDA, other government agencies, academia, and business and industry.  In-person attendees participate in laboratory activities conducted in mock Biosafety Level (BSL) 2, 3, and 4 training laboratories to emphasize the differences between biosafety levels and the complexity of conducting laboratory activities in a BSL4 laboratory environment.

Generic Drugs Forum (GDF) 2026

Day 1: Wednesday, April 22, 2026; 9 a.m. – 5 p.m. ET
Day 2: Thursday, April 23, 2026; 9 a.m. – 5 p.m. ET

The annual Generic Drugs Forum is a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines.  This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment programs, offering unparalleled insights and guidance.  Attendees will gain practical regulatory knowledge to enhance their applications, streamline the assessment process, and reduce cycles.  The forum's primary goal is to support prospective and current applicants in submitting complete and high-quality submissions, ultimately ensuring timely access to affordable medications that benefit public health.

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.