March 2, 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. 27, 2026 - FDA Seeks Feedback from Rare Disease Community
• Feb. 26, 2026 - FDA Grants Second Approval under the National Priority Voucher Pilot Program
• Feb. 26, 2026 - FDA Augments and Improves Infant Formula Resources to Enhance Transparency, Safety, and Access for American Families
• Feb. 26, 2026 - Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
• Feb. 26, 2026 - Product-Specific Guidances for Generic Drug Development
• Feb. 25, 2026 - Investigations of Foodborne Illness Outbreaks
• Feb. 25, 2026 - 2025 DARS Annual Report
• Feb. 25, 2026 - Feedback Requested: FDA Rare Disease Day 2026
• Feb. 24, 2026 - Accelerating Rare disease Cures (ARC) Program
• Feb. 24, 2026 - FDA Establishes Regulatory Program Standards to Strengthen Produce Safety Oversight Activities with States
• Feb. 24, 2026 - FDA Grants Traditional Approval to Encorafenib for Metastatic Colorectal Cancer with a BRAF V600E Mutation
• Feb. 23, 2026 - FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases

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:

• Infusion Pump Software Correction: Fresenius Kabi Ivenix LVP
• Early Alert: Heart Pump Purge Cassette Issue from Abiomed

Guidance Documents

• Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause

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.

FDA Direct

Combating Rare Diseases at the FDA

FDA Voices

Why Protecting Confidential Information is Key to the FDA’s "Gold Standard"

By: Barclay Butler, Ph.D., Deputy Commissioner for Operations and Chief Operating Officer

When Americans look to the U.S. FDA, they are expecting to see the "Gold Standard" of regulatory review—the rigorous scientific scrutiny that determines whether a new therapy, medical device, or food process is safe and effective.  Behind every one of these critical decisions lies one of the world’s most sensitive repositories of intellectual property and personal data.

Webinars and Virtual Workshops

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.