April 20, 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 17, 2026 - FDA Renews Authorization for Five IQOS Products to be Marketed with Exposure Modification Claims
- April 17, 2026 - FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Recalled Shellfish from a Portion of Hammersley Inlet, WA, Due to Potential Norovirus Contamination
- April 16, 2026 - First FDA - Approved Treatment for Patients with Focal Segmental Glomerulosclerosis - A Rare Kidney Condition
- April 16, 2026 - FDA Issues a Letter to Industry on Nitrosamine Impurities
- April 16, 2026 - FDA and NIH Study: Population Assessment of Tobacco and Health
- April 16, 2026 - FDA Takes Step Forward on Testosterone Therapy for Men
- April 16, 2026 - Outbreak Investigation of E. coli O157:H7: Raw Cheddar Cheese (March 2026)
- April 15, 2026 - Investigations of Foodborne Illness Outbreaks
- April 14, 2026 - FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development
- April 13, 2026 - FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
- April 13, 2026 - FDA Releases FY25 Sampling Results on Economically Motivated Adulteration in Honey
MedWatch: 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:
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. FDA VoicesBy: JaCinta S. Batson, M.S., M.B.A., Director, Satellite Laboratory Branch, National Forensic Chemistry Center, Office of the Chief Scientist| Satellite laboratories stationed inside high-volume international mail facilities at airports in Chicago, New York, Los Angeles, Miami—and now Honolulu—are one of the U.S. Food and Drug Administration’s numerous weapons in combating counterfeit and other potentially harmful drugs. The goal of the chemists working in these laboratories is to analyze and stop suspicious imported drugs—some containing potentially lethal, never-before-seen substances—before they can harm the public. |
Webinars and Virtual WorkshopsDay 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; 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. 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: Wednesday, April 29, 2026; noon - 1 p.m. ET
This webinar will highlight how the RCT-DUPLICATE initiative evaluates when and how non-randomized healthcare database studies have generated valid causal inferences, using randomized controlled trial findings as a benchmark. The initiative has demonstrated that results have been strongly concordant when those studies closely emulated trial designs and has helped clarify when and why divergence may occur. 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. 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. 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. Date: Wednesday, May 6, 2026; 3 - 4 p.m. ET
In recognition of National Nurses Week, the FDA Oncology Center of Excellence will convene a Conversations on Cancer discussion to spotlight the critical role nurses play as frontline professionals in oncology drug development through their involvement in clinical trials, research coordination, patient care, and education. While their responsibilities extend from direct patient interaction to significant contributions in the research and pharmaceutical industries, their expertise and contributions are often underrepresented and underrecognized in the drug development process. This conversation opens dialogue between frontline nurses and regulatory professionals regarding their roles in cancer treatment and how nursing insights can inform oncology product development, clinical trial participation, and the patient experience. 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. Date: Thursday, May 7, 2026; 3 - 4 p.m. ET
This presentation shares laboratory findings on the rapidly changing composition of the U.S. illicit drug supply, and trends in overdose mortality. Topics include emerging synthetic substances and notable regional variations. Current declines in overdose deaths will be placed in both national and historical context. The presentation emphasizes data-driven insights alongside real-world narratives to make the complexities of supply-side surveillance accessible to a broad audience. CERSI-funded research on drug treatment and pharmacology will help connect the importance of scientific research in understanding the rapidly evolving drug environment. 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. 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. Date: Monday, May 18, 2026; 12:30 - 4:30 p.m. ET
The FDA Oncology Center of Excellence (OCE) is holding a workshop to discuss several topics related to the ongoing evolution of the landscape of therapies for NMIBC, including the similarities and differences, from the perspectives of molecular biology, clinical pathology, urology, and medical oncology, of the two major types of histology [papillary and carcinoma in situ (CIS)] observed in NMIBC as well as the current state of the Bacillus Calmette-Guérin (BCG) shortage and implications of this shortage for clinical trial design. 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 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. |
