October 13, 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: Diagnostic Ultrasound System Issue from Philips Ultrasound
• RAPTURE Preworkout by Leader Formulas
• One Lot of Babies' Magic Tea Brand Baby Sleep Gripe Water Dietary Supplement by Pacific Health Sciences
• IV Tubing Set Correction: ICU Medical Updates Use Instructions for IV Tubing Sets
• Infusion Set Recall: BD and CareFusion 303, Inc. Remove BD Alaris Pump Infusion Sets

Updates

• Oct. 9. 2026 - FDA Issues Final Rule on Salt Substitutes in Standardized Foods
• Oct. 8, 2026 - Request for Information; Domestic and Near Shore Manufacturing of Essential Medicines on the ASPR 86 List
• Oct. 8, 2026 - Food Traceability: FDA Issues Draft Enforcement Discretion Policy for Certain Small Retailers and Restaurants and Announces Public Meeting
• Oct. 7, 2026 - FDA Approves Tucatinib with Trastuzumab and Pertuzumab for the Maintenance Treatment of HER2-Positive Breast Cancer
• Oct. 6, 2026 - FDA Releases the CORE+EP 2025 Annual Report: Investigations of Foodborne Outbreaks and Adverse Events in FDA-Regulated Foods
• Oct. 5, 2026 - FDA Releases In-Country Assessment Report on Cesium-137 Import Certification Program for Indonesian Shrimp and Spice Products
• Oct. 5, 2026 - FDA Seeks Public Input to Support Ibogaine Research

FDA Voices

Advisory Committees Give FDA Critical Advice and the Public a Voice

At the U.S. FDA, we rely on our many advisory committees to help us make sound decisions based on the best science available.  The FDA’s complex and multifaceted mission includes evaluating new medical devices and medicines, including vaccines and other therapies, to determine if they are safe and effective for their intended use.  FDA advisory committees give our own agency experts outside, independent, and professional advice on various complex scientific, technical, and policy issues.  Good scientific deliberation benefits from a range of qualified voices and perspectives.  Advisory committees work because they bring perspectives that are independent of the FDA, from the research bench, the clinic, and the community.  Advisory committee meetings can include a broad scientific discussion about important topics.  They can also be more focused on a specific product under FDA review.

Guidance Documents

• Questions and Answers on Biosimilar Development and the BPCI Act
• Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers
• Study Data Technical Conformance Guide - Technical Specifications Document
• Guidance for Industry: Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants

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

FDA/Center for Research on Complex Generics (CRCG) Workshop on Advancing Bioequivalence Frameworks for Inhalation Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods

Day 1: Wednesday, Oct. 14, 2026; 8 a.m. - 5:30 p.m. ET
Day 2: Thursday, Oct. 15, 2026; 8 a.m. - 5:30 p.m. ET

Attendees will gain valuable insights into the current understanding, regulatory expectations, and industry experiences with developing, validating, and using in vitro and in vivo methods included as part of bioequivalence recommendations for metered dose inhalers (MDIs) and dry powder inhalers (DPIs) without significant formulation differences from their reference standard (RS).  The final session of the workshop will explore the potential for using innovative in vitro and in vivo methods in these option-based frameworks with products containing significant formulation differences from their RS.  In addition to a series of expert-led presentations and panel discussions, in-person attendees will interact directly with experts from industry, academia, and regulatory agencies to better understand the current practices and considerations for conducting these studies.

Navigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations

Date: Wednesday, Oct. 14, 2026; noon - 1 p.m. ET

In January 2026, the Agency published the draft guidance “Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products” to address a PDUFA VII commitment.  The guidance discusses important considerations such as success criteria and operating characteristics, the use of external information in a prior distribution, estimands and missing data in a Bayesian setting, software and computation, and how to document and report Bayesian analyses.

FDA Workshop: 11th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop

Date: Thursday, Oct. 15, 2026; 1 - 4 p.m. ET

The FDA Oncology Center of Excellence will host the 11th Annual COA-CCT Workshop on October 15, 2026.  This year's workshop asks a defining question: after more than a decade of progress in patient-reported outcome science, are we truly measuring what matters most to patients?  The workshop features two panel sessions, with the majority of panelists being patient advocates with personal cancer experience.  Session 1 examines critical gaps in current outcome frameworks driven by novel therapies, longer survivorship, and the need for more frequent and real-time data collection.  Session 2 takes a forward-looking view, exploring patient co-design, emerging technologies, and actionable milestones for sponsors and the research community.  Together, the sessions advance FDA OCE's patient-focused drug development mission.

Webinar on FDA’s Generally Recognized as Safe (GRAS) Proposed Rule

Date: Thursday, Oct. 15, 2026; 2 - 3 p.m. ET

On August 10, 2026, the FDA proposed a rule to enhance oversight of uses of substances added to human and animal food that are claimed to be Generally Recognized as Safe (GRAS).  On October 15, 2026, FDA is hosting a live webinar to describe the proposed rule.  The FDA is seeking public feedback on the GRAS proposed rule to ensure the approach in a final rule protects public health and enhances transparency.  Electronic comments may be submitted to Regulations.gov using docket number FDA-2025-N-3262.  Written comments should be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.  All written comments should identify the docket number FDA-2025-N-3262.  The comment period is open until December 9, 2026.

Patient Voice in Rare Disease Medical Product Development

Date: Friday, Oct. 16, 2026; 1 - 5 p.m. ET

On October 16, 2026, the U.S. FDA, in partnership with the Reagan-Udall Foundation for the FDA (Foundation), will convene a hybrid meeting to explore the patient voice in rare disease medical product development (biologic, drug, and device).  The meeting will explore where the patient voice is sought across the development timeline, its impact, and additional opportunities for patients to engage in the product development process.  Insights from these discussions will help inform recommendations for product developers and regulators to consider as they advance patient-centered approaches in their work.

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

ICYMI!

Applying for Membership on FDA Advisory Committees

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.