April 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 Public Engagement Staff
Public Engagement Staff | FDA

Updates

• April 9, 2026 - FDA Issued its First Warning Letter to a Dispenser (a Medical Spa) for Violating the Drug Supply Chain Security Act (DSCSA)
• April 8, 2026 - Investigations of Foodborne Illness Outbreaks
• April 8, 2026 - Outbreak Investigation of E. coli O157:H7: Raw Cheddar Cheese (March 2026)
• April 7, 2026 - FDA READI-Home Innovation Challenge: Reducing Readmissions through Device Innovation for the Home
• April 7, 2026 - Optimizing Pregnancy Registries Public Workshop
• April 7, 2026 - 2025 Office of Clinical Pharmacology (OCP) Annual Report
• April 7, 2026 - FDA Has Issued 7 Warning Letters Linked to 20+ Violative Products with Concerns about GLP-1 and Other Products Sold to Consumers Marked for “Research Purposes” or “Not for Human Consumption”
• April 6, 2026 - FDA Approves First Generic Omeprazole Oral Paste for Gastric Ulcers in Horses

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:

• Wound Care Gel Products by Blaine Labs
• Early Alert: Convenience Kit Issue from AVID Medical
• Angiographic Syringe Recall: Medline Industries Removes Namic Angiographic Rotating Adaptor Control Syringes
• Early Alert: Sizing Catheter Issue from Cook Medical

Guidance Documents

• Bioanalytical Method Validation for Biomarkers

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!

Project Facilitate

Oncology Center of Excellence 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

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.

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 Grand Rounds Presented by the Office of Women’s Health: FDA Menopausal Hormone Therapy (MHT) Labeling: Historical Context and Recent Changes

Date: Thursday, April 23, 2026; noon - 1 p.m. ET

This lecture will provide the historical and regulatory context of menopausal hormone therapy (MHT) which led to the creation of the Women's Health Initiative studies, as well as the results of those studies and the subsequent impact.  The lecture will also describe the rationale for the FDA’s requests to update the MHT labeling and describe the labeling changes in each of the four MHT product categories.

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.

Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products

Day 1: Tuesday, May 5, 2026; 8:30 a.m. - 5:30 p.m. ET
Day 2: Wednesday, May 6, 2026; 8:30 a.m. - 5:30 p.m. ET

The field of generic oral drug products continues to evolve leading to innovative bioequivalence (BE) approaches when conventional in vivo bioequivalence study designs may not be feasible.  In response to these evolving complexities, this workshop is designed to address the latest advancements and regulatory challenges in the field, offering a unique platform to engage with all relevant parties, share knowledge, and contribute to the evolution of generic oral product development and regulatory assessment.

Optimizing Pregnancy Registries Public Workshop

Day 1: Thursday, May 7, 2026; 9 a.m. - 4:15 p.m. ET
Day 2: Friday, May 8, 2026; 9 a.m. - 12:40 p.m. ET

The FDA is announcing the public workshop, "Optimizing Pregnancy Registries."  The purpose of the public workshop is to discuss challenges in designing and implementing pregnancy registries and to consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy.

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.

Advancing Novel Surrogate Endpoints For Rare Disease Drug Development Workshop

Date: Monday, May 18, 2026; 9 a.m. - 4:30 p.m. ET

FDA is convening a one-day virtual public workshop on May 18, 2026, focused on the development of surrogate endpoints for drugs and biological products intended to treat rare diseases.  The workshop will discuss mechanistic and translational evidence considerations for supporting a novel surrogate endpoint in rare disease marketing applications, including a case study highlighting the evidentiary package to support the use of a novel surrogate endpoint.  FDA, clinicians, researchers, and other stakeholders will also discuss various relevant and or emerging translational science topics to support the development of novel surrogate endpoints such as new approach methodologies, digital health technology, and harnessing varied sources of patient-level real world data.

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 p.m. 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.