April 6, 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

• April 3, 2026 - Outbreak Investigation of E. coli O157:H7: Raw Cheddar Cheese (March 2026)
• April 3, 2026 - FDA Advises Consumers, Retailers, and Distributors Not to Eat, Sell, or Distribute Addall XR Shot or Addall XL Dietary Supplements (April 2026)
• April 1, 2026 - Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
• April 1, 2026 - Outbreak Investigation of Extensively Drug-Resistant Salmonella: Moringa Powder (February 2026)
• April 1, 2026 - FDA Approves First New Molecular Entity Under National Priority Voucher Program
• April 1, 2026 - Investigations of Foodborne Illness Outbreaks
• March 31, 2026 - FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (Avacopan) for Severe Active Anti-Neutrophil Cytoplasmic Autoantibody (ANCA)-Associated Vasculitis 
• March 31, 2026 - FDA Seeks Public Input on Potential Market Name Change for Certain Rockfish Species

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:

• Kian Pee Wan Capsules by Aphreseller (Buy-herbal.com)

Guidance Documents

• Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle

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

Special Edition of FDA Direct

Commissioner Makary and other members of FDA leadership, as well as guests, engage in timely and frank discussions to bring you an inside look at the current happenings at the FDA.

FDA Voices

Real-World Evidence: Advancing Regulatory Decision-Making for Medical Devices

By: Daniel Caños, Ph.D., MPH, Director, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health (CDRH) and Michelle Tarver M.D., Ph.D., Director, CDRH

Today’s health care ecosystem is generating richer and more diverse data streams, providing new opportunities to modernize how Real-World Data (RWD) generates relevant and reliable Real-World Evidence (RWE).  The U.S. FDA is working to provide clearer recommendations and more consistent acceptance of RWE as valid scientific evidence.  RWE is the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.  Appropriately validated RWE can support a broad range of regulatory activities, including serving as the primary clinical evidence in premarket submissions.

ICYMI!

Project Facilitate

Oncology Center of Excellence (OCE) Project Facilitate is a single point of contact call and information center created to help oncology healthcare providers or regulatory professionals submit an Expanded Access Request (also referred to as: Compassionate Use, Emergency IND, Single-Patient IND, or Pre-Approval) for an individual patient with cancer through FDA's Expanded Access Program.  FDA’s Expanded Access Program allows patients with life-threatening diseases or conditions such as cancer to try investigational medical products (drug, biologic, or medical device) when no satisfactory therapies are available and there is no opportunity for the patient to enroll in a clinical trial.

Webinars and Virtual Workshops

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.

FDA Grand Rounds – Clinical Omics Biomarker Discovery and Validation in Precision Medicine Applications

Date: Thursday, April 9, 2026; noon - 1 p.m. ET

This lecture will provide an overview of Systems Biology omics and biomarker concepts with four examples of omics analyses of human blood samples.  The examples include metabolomics and miRNA analysis of serum during acetaminophen-induced liver toxicity, proteomic analysis of serum to predict kidney recovery from dialysis, baseline proteomics analysis of blood from patients receiving doxorubicin treatment, and method for discovery and validation of miRNA-proteins pairs in plasma associated with respiratory disease.

Scaling Innovative Clinical Trial Approaches: Challenges, Progress, and Opportunities

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.

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. – 5:25 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.

FDA Public Meeting on Increasing Access to Nonprescription Drugs

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.

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.

OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration

Date: Tuesday, May 5, 2026; 1 - 2 p.m. ET

The webinar provides an overview of the Over-the-Counter Drug User Fee Amendments (OMUFA) and describes the key elements of the amendments as it relates to OMUFA user fees.

Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma

Date: Tuesday, May 12, 2026; 9 a.m. - 2 p.m. ET

This webinar is intended to provide blood establishments and other stakeholders with an overview of Office of Blood Research and Review (OBRR) approach to the review of biologics license applications for the manufacture of blood and blood components, including Source Plasma.  In this event, OBRR staff will give presentations on select topics and address questions submitted by registrants.

Regulatory Education for Industry (REdI) Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products

Day 1: Tuesday, May 19, 2026; 9 a.m. - 4:50 pm ET
Day 2: Wednesday, May 20, 2026; 9 a.m. - 3:50 p.m. ET

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics.  This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.

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.