NYSDA Publications

FDA Issues Regulatory Update

Aug 24, 2026

August 24, 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

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:

Updates

Spotlight

FDA Public Meeting: Testosterone Use In Menopausal Women

The purpose of the workshop is to examine the current scientific evidence and critical knowledge gaps related to testosterone use in menopausal women to help inform future research and potential drug development in this area.

FDA Voices

FDA Weighs in on the Development and Use of Digitally Derived Measures for Clinical Investigations

By: Rick Abramson, M.D., Director, Digital Health Center of Excellence

For decades, much of what we have known about a participant’s health during a clinical investigation has been shaped by what could be observed, measured, or reported during periodic visits to a research site or clinic.  Among the most promising opportunities in healthcare today is the use of digital health technologies (DHTs) that are expanding that window.  DHTs, especially those enabled by artificial intelligence, can capture information about a person’s health continuously, in real time, and in the context of a person’s everyday life.  These technologies can bring clinical investigation closer to participants and patients in their daily lives and at various stages along their health journey.  DHTs also enable earlier detection of treatment effects or safety signals and may facilitate decentralized clinical trials.

Guidance Documents

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 Workshops

FDA Public Meeting: FDA-Led Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds

Date: Tuesday, Aug. 25, 2026; 10 a.m. - 4:30 p.m. ET

On August 25, 2026, the U.S. FDA is hosting a hybrid public meeting on Patient-Focused Drug Development for Nonhealing Chronic Wounds.  This meeting will provide FDA and other key stakeholders, including medical product developers, health care providers, and academic researchers, the opportunity to hear directly from patients, patient representatives, and care partners about their experiences with nonhealing chronic wounds, including how the wounds and associated wound care affect their daily life, what matters most to them, their current approaches for managing or treating their nonhealing chronic wounds, and what they consider when determining whether to participate in a clinical trial.

Advancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs

Date: Thursday, Aug. 27, 2026; 8:30 a.m. - 12:30 p.m. ET

This half-day workshop includes a series of expert-lead presentations and audience Q&A sessions focused on the latest advancements and regulatory considerations in the evolving field of Model-Integrated Evidence (MIE)-supported generic drug development and approval.  Attendees at this workshop will gain valuable insights into FDA's regulatory expectations for MIE submissions, learn practical strategies for avoiding common pitfalls, and hear real-world case studies demonstrating how MIE has successfully supported FDA guidance development and generic drug approvals.

FDA Virtual Workshop on Digital Health Technologies and Statistical Considerations for Digitally-Derived Endpoints in Clinical Trials

Date: Thursday, Aug. 27, 2026; 9:30 a.m. - 3:45 p.m. ET

The FDA is hosting a free virtual public workshop, convened by the Duke-Margolis Institute for Health Policy under a cooperative agreement with the FDA, to discuss statistical considerations for digitally-derived endpoints in clinical trials for drug and biological products.  Speakers will provide updates on FDA efforts under PDUFA VII to advance the use of digital health technologies (DHTs) in drug development and regulatory review.  Discussions will also explore opportunities to strengthen data standards and innovative analytical methods that support the broader use of clinically meaningful, digitally-derived endpoints in clinical trials for drug and biological products.  Speakers will also discuss the Submitting Continuous Glucose Monitoring Data in Clinical Trials Technical Specifications Document to provide foundational background for regulatory submissions for drug and biological product evaluation, device performance assessment, and analytical best practices.

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.