FDA Issues Regulatory Update
April 27, 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
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:
- Early Alert: Dialysis Catheter Kit Issue from Arrow International
- Early Alert: Automated Compounding System Issue from Omnicell
- Early Alert: Convenience Kit Issue from Aligned Medical Solutions
Updates
- April 24, 2026 - FDA Issues Emergency Use Authorization for Ointment to Prevent and Treat New World Screwworm in Multiple Species, Including Cattle, Sheep, Goats, Horses, Wild and Exotic Mammals, Wild and Pet Birds
- April 24, 2026 - FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order
- April 23, 2026 - FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
- April 23, 2026 - Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
- April 23, 2026 - CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices
- April 22, 2026 - FDA Announces Public Meeting on Challenges and Solutions for Lot-Level Traceability
- April 21, 2026 - Investigations of Foodborne Illness Outbreaks
- April 21, 2026 - Opiate Alkaloids on Poppy Seeds
- April 20, 2026 - FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
Spotlight
FDA Oncology Center of Excellence Presents Conversations on Cancer: Oncology Nurses - Frontliners in Oncology
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.
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.
Webinars and Virtual Workshops
FDA Webinar on the RCT-DUPLICATE Initiative: Emulating Randomized Clinical Trials with Non-Randomized Real-World Data Studies
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.
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
ICYMI!
Tobacco Education Resources for Parents and Teachers
As youth e-cigarette use remains a public health issue, it is important that parents and educators have access to resources to learn more and to start an honest conversation with teens about the dangers of youth tobacco use. FDA has free resources available, including videos, infographics, posters, and fact sheets.
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.
