May 24, 2024

Dear Colleague,

While the FDA continues to focus on protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products, we also recognize the work of our public health partners. As public health advocates, we know that your work to better our country is invaluable. Your partnership, knowledge and engagement in the public health space are appreciated.

Updates

• May 21, 2024 - FDA Roundup
• May 17, 2024 - FDA Roundup
• May 14, 2024 - FDA Roundup

FDA Voices

FDA Promotes Clinical Trial Innovation

By: Hilary Marston, MD, MPH, Chief Medical Officer and Kevin Bugin, PhD, Deputy Director of Operations in the Office of New Drugs, Center for Drug Evaluation and Research

Guidance Documents

CVM GFI #115 (VICH GL22) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Toxicity Testing (Revision 1)

The objective of this guidance is to ensure international harmonization of reproduction toxicity testing, which is appropriate for the evaluation of effects on reproduction from long-term, low-dose exposures, such as may be encountered from the presence of veterinary drug residues in food.

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

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration

June 18, 2024; 1:00 - 2:00 p.m. ET 

The webinar provides an overview of the Over-the-Counter Drug User Fee Program (OMUFA) and describes the key elements of the program as it relates to OMUFA user fees.

FDA WORKSHOP: 9th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop

June 25, 2024; 11:00 a.m. - 2:30 p.m. ET

The FDA Oncology Center of Excellence (OCE) Patient-Focused Drug Development (PFDD) program welcomes you to the Clinical Outcome Assessment in Cancer Clinical Trials (COA-CCT) 9th annual workshop.

View Upcoming FDA Meetings, Conferences and Workshops

Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts

About Us

The Stakeholder 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, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov.