NYSDA Publications

FDA Issues Regulatory Update

Mar 23, 2026

March 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

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:

Guidance Documents

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!

Women's History Month

American women have changed the landscape of scientific health research, medicine, and public health.  In commemoration of Women’s History Month at FDA, we are highlighting the contributions of a number of pioneering women who made significant and long-lasting contributions to public health during their careers with the FDA.

Webinars and Virtual Workshops

Public Meeting Exploring the Scope of Dietary Supplement Ingredients

Date: Friday, March 27, 2026; 9 a.m. - 3 p.m. ET

FDA’s Office of Dietary Supplement Programs (ODSP) invites stakeholders to participate in a public meeting to discuss the evolving landscape of dietary supplement ingredients and how recent scientific and technological advances are shaping the industry.

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.

Town Hall – FDA’s Quality Management System Regulation (QMSR): Medical Device Risk-Based Inspections

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

The FDA will host a town hall for industry and other interested parties to discuss the updated Inspection of Medical Device Manufacturers Compliance Program (CP) Manual (CP 7382.850), effective February 2, 2026.  This CP includes the new inspection process, which aligns with the requirements of the Quality Management System Regulation (QMSR).

Advancing Pediatric Cell and Gene Therapy Clinical Trials: Scientific, Ethical, Regulatory, and Practical Considerations

Date: Thursday, April 9, 2026; 9 a.m. - 4:30 p.m. ET

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP), and the Alliance for Regenerative Medicine (ARM) are co-hosting a hybrid workshop on April 9, 2026, titled “Advancing Pediatric Cell and Gene Therapy Clinical Trials.”  The workshop will explore the issues surrounding clinical trials for cell and gene therapies (CGTs) in pediatric populations, particularly for diseases where earlier intervention may result in greater therapeutic benefit.  This includes conditions that affect both pediatric and adult populations, as well as diseases that occur primarily in children.

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 a.m. – 4:30 p.m. 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 Public Meeting on Increasing Access to Nonprescription Drugs

Date: Thursday, April 23, 2026; 12:30 - 5:00 p.m. ET

The FDA is announcing a public meeting and comment period, “Increasing Access to Nonprescription Drugs.”  The meeting will bring together experts to discuss perspectives on expanding access to nonprescription or over-the-counter (OTC) drugs.  Making more drugs available over the counter can decrease medication costs and improve access to important treatments.  The public meeting will discuss perspectives on increasing access to nonprescription drugs from interested parties, including drug developers, healthcare professionals, and consumers, among others.  FDA is particularly interested in practical considerations that shape nonprescription drug access.

Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

Date: Thursday, April 30, 2026; 8 a.m. - 5 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.

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.