NYSDA Publications

FDA Issues Health Care Stakeholders Update

Apr 7, 2025

The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders.  You can read the FDA regulatory update for stakeholders below.

April 7, 2025

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

Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner

Renowned surgeon-scientist and health policy expert, Martin A. Makary, M.D., M.P.H., took the oath of office to become the 27th Commissioner of Food and Drugs. Dr. Makary was confirmed by a bipartisan vote of the U.S. Senate. Dr. Makary’s accomplishments as a researcher, clinician and prolific author are numerous. He has authored more than 300 peer-reviewed articles in medical literature and founded the Johns Hopkins Center for Surgical Trials and Outcomes Research. Dr. Makary has led cross-disciplinary research on a range of subjects including cancer care, obesity, frailty and psychologic reserve in older patients, adverse event monitoring, the Orphan Drug Act, antimicrobial resistance, and Alzheimer’s. Of note, he is the co-developer of the Surgery Checklist used in many operating rooms around the world today. A member of the prestigious National Academy of Medicine, Dr. Makary has been a visiting professor at more than 25 medical schools across the U.S. and internationally.

Updates

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:

Guidance Documents

Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff

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

Generic Drugs Forum (GDF) 2025

April 9 - 10, 2025

Day 1: Wed, Apr 9; 8:30 a.m. - 5:00 p.m. ET
Day 2: Thu, Apr 10; 8:30 a.m. - 5:00 p.m. ET

Join us at the annual Generic Drugs Forum, 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.

Updated “Healthy” Claim Webinar Rescheduled

Date: Thu, Apr 10; 1:00 - 2:00 p.m. ET

The FDA invites the public to register for a webinar on the FDA Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” Final Rule. The purpose of this webinar is to provide an overview of the final rule and answer pre-submitted questions. The webinar is open to new registrants, but you do not need to re-register if you previously signed-up for this event.  A separate communication will be sent to anyone previously registered to confirm their event registration and the new event date and time.

Implementing FDA’s IVPT Guidance Recommendations: A Step-By-Step Illustration - Workshop

April 29 - 30, 2025

Day 1: Tue, Apr 29; 8:30 a.m. - 5:30 p.m. ET
Day 2: Wed, Apr 30; 8:30 a.m. - 3:30 p.m. ET

The In Vitro Permeation Test (IVPT) is an important performance test used by the generic drug industry to support demonstrations of bioequivalence for generic topical drug products, when utilizing efficient characterization-based bioequivalence approaches. The workshop will clarify the intent of FDA recommendations for IVPT studies, with step-by-step demonstrations illustrating how IVPT study procedures can be performed in a manner compatible with recommendations in FDA’s Guidance for Industry.

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.