March 30, 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 UpdatesMedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe 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:
Consumer UpdatesThe genes in your body’s cells play a key role in your health. Indeed, a defective gene or genes can make you sick. Recognizing this, scientists have worked for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure, or prevent a disease or medical condition. This research is paying off, as advancements in science and technology today are changing the way we define disease, develop drugs, and prescribe treatments. The U.S. FDA has approved multiple gene therapy products for cancer and rare disease indications. Guidance DocumentsView 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!The evidence is clear - screening for colorectal cancer may save your life. Today, more and more people are choosing colorectal cancer screening. As a result, there is a steady decline in the number of older people getting and dying from colorectal cancer. Lower rates of smoking among Americans have also contributed to the decline in the past several years. Colorectal cancer usually starts from polyps or other precancerous growths in the rectum or the colon (large intestine). The only way to find a polyp, precancerous growth, or colorectal cancer is to do a screening test or procedure. The benefits of screening are so great that doctors recommend most people start colorectal cancer screening by age 45. Some people who are at higher risk may need to start screening before age 45. Webinars and Virtual WorkshopsDate: 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. 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). 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. Date: Tuesday, April 14, 2026; 9 a.m. - 4:30 p.m. ET
This hybrid workshop, co-convened by the Duke-Margolis Institute for Health Policy and the U.S. FDA Center for Drug Evaluation and Research (CDER), Center for Clinical Trial Innovation (C3TI), will explore progress in clinical trial innovation to improve the efficiency of drug development. The meeting will highlight C3TI’s activities, including the C3TI Demonstration Program, and emerging priorities. Sessions will discuss lessons learned from recent efforts, the benefits of adopting innovative approaches in clinical trials, and persistent challenges. Participants will discuss strategies to bridge from policy to implementation to broader adoption of innovative approaches in the design and conduct of clinical trials. 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. 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. Day 1: Wednesday, April 22, 2026; 9 a.m. – 5:25 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. Date: Thursday, April 23, 2026; 12:30 - 5 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. 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 UsThe 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. |
