October 26, 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 Office of Public Engagement

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: Cardinal Health Updates Use Instructions for Presource Packs
• Early Alert: Cardinal Health Presource Pack Correction
• Nova Biomedical Removes StatStrip Glucose Hospital Meter Systems

Updates

• Oct. 23, 2026 - FDA Approves First Once-Weekly Insulin for Type 2 Diabetes Mellitus in Pediatric Patients
• Oct. 23, 2026 - FDA Advises Not to Eat, Sell, or Serve Cold Smoked Sprats Sold by Haifa Smoked Fish, Inc.
• Oct. 22, 2026 - The Center for Drug Evaluation and Research's ARC Program Releases its 2026 Annual Report
• Oct. 22, 2026 - FDA Launches New Program to Advance Neuroscience Medical Product Development
• Oct. 22, 2026 - Recording Now Available: 50-State Call - 2026 FDA Food Code & TCS Updates
• Oct. 22, 2026 - FDA Advances Closer to Zero Initiative to Safeguard Food for Children
• Oct. 20, 2026 - FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
• Oct. 20, 2026 - FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
• Oct. 20, 2026 - FDA Approves Ready-to-Use Cefovecin Injectable for Treatment of Certain Skin Infections in Dogs
• Oct. 20, 2026 - Predetermined Change Control Plans
• Oct. 20, 2026 - FDA Issues Final Guidance on Prescription Drug Apps and Software
• Oct. 19, 2026 - CTP Announces Its Next Director of the Office of Compliance and Enforcement
• Oct. 19, 2026 - Safety Alert for Salmonella: Oysters from Little Wicomico River, Virginia
• Oct. 19, 2026 - FDA Releases Sampling Results on Economically Motivated Adulteration in Lemon Juice
• Oct. 19, 2026 - FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery
• Oct. 19, 2026 - FDA Issues Guidance on Identity and Safety Information for New Dietary Ingredient Notifications

Spotlight

Draft Guidance for Industry: U.S.-Origin Statements on Seafood

The FDA published draft guidance to help companies proudly and accurately label seafood of U.S. origin.  If finalized, the guidance would provide examples of statements, such as “U.S.-Caught,” and graphics featuring the American flag that companies could use to help consumers identify and choose U.S. seafood.

Guidance Documents

• Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry
• Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food
• Action Levels for Cadmium in Processed Food Intended for Babies and Young Children: Draft Guidance for Industry
• Regulatory Considerations for Prescription Drug Use-Related Software
• Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues
• Guidance for Industry: New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI
• Safety Reporting Requirements for INDs and BA/BE Studies
• Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle

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.

Meetings, Conferences and Workshops

Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA)

Date: Monday, October 26, 2026; 9 a.m. - noon ET

The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032.

FDA Rare Disease Framework Initiative Public Meeting

Date: Wednesday, October 28, 2026; 1 - 5 p.m. ET

The U.S. FDA, in partnership with the Reagan-Udall Foundation for the FDA, will convene a hybrid public meeting to seek input related to the FDA’s Rare Disease Framework Initiative to reimagine the agency’s approach to rare disease drug development.  The intent of this new initiative is to develop a fit-for-purpose Framework that reflects the realities of rare disease drug development by considering the nuances of each disease, patient needs, product type, and the evidence that realistically can be generated in small patient populations.

Webinar for Stakeholder Engagement on the New Final Guideline on General Principles for Model-Informed Drug Development (ICH M15)

Date: Thursday, October 29, 2026; 8:30 - 10 a.m. ET

This webinar presents the final M15 guideline, explaining the concepts introduced in the guideline, illustrating them through a case example, and addressing common questions about applying these principles.

FDA Oncology Center of Excellence Presents Conversations on Cancer: Navigating Cancer Resources in the Digital Age

Date: Thursday, October 29, 2026; 2 - 3 p.m. ET

This panel explores how patients with cancer and caregivers of patients with cancer navigate online health information in an increasingly digital healthcare environment.  With the rise of tools like patient portals, telehealth, and AI-driven search, finding clear, evidence-based information has become both easier and more complex.  Panelists will discuss the link between health literacy and digital literacy, focusing on how patients can identify dependable resources and make informed care decisions.  The session will also offer practical strategies to support confident, effective use of digital health technologies in an era of information abundance.

Dermatologic and Ophthalmic Drugs Advisory Committee Meeting Announcement

Date: Friday, October 30, 2026; 8:30 a.m. - 3 p.m. ET

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science.  Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.  Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

ICYMI!

Phase 1 IND Frequently Asked Questions

About Us

The Office of Public Engagement resides within the Office of the Commissioner and falls under the Office of Public 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.