June 7, 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

• June 4, 2024 - FDA Roundup
• May 31, 2024 - FDA Roundup

FDA Voices

Join Us in Recognizing National Black Family Cancer Awareness Week

By: Richard Pazdur, MD, Director, Oncology Center of Excellence (OCE), and Rea Blakey, Associate Director for External Outreach and Engagement, OCE

If you’ve ever heard the inspirational quote, “Be the change you wish to see,” the U.S. Food and Drug Administration Oncology Center of Excellence (OCE) has an opportunity for you. Join the “4th Annual National Black Family Cancer Awareness Week, Engaging the Generations” initiative and the #BlackFamCan social media campaign this year, June 13-19. The event is virtual and open to the public. Register now for the June 13 Conversations on Cancer public panel discussion which will be live streamed from 2:30 – 4:00 p.m. ET.

In the US, Blacks have the highest cancer death rate for most leading cancer types. National Black Family Cancer Awareness Week is an effort to raise awareness about this disparity and to highlight the importance of family cancer history, prevention, screening, and clinical trials. Participants can engage online throughout the week via any social media platforms they choose. Participants are also urged to remain committed to coordinating their own in-person activities.

Guidance Documents

Processes and Practices Applicable to Bioresearch Monitoring Inspections

The draft guidance is being issued to comply with the Food and Drug Omnibus Reform Act of 2022, which directs the Agency to issue guidance describing the processes and practices applicable to inspections of sites and facilities inspected under FDA’s Bioresearch Monitoring inspection program, to the extent not specified in existing publicly available FDA guides and manuals.

Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center of Biologics Evaluation and Research Submissions

This draft guidance applies to electronic submissions of data and information from the major (i.e., pivotal) studies  used to support safety and efficacy claims in biologics license applications (BLAs) and new drug applications (NDAs) regulated by the Center for Biologics Evaluation and Research (CBER), as well as supplemental applications containing new clinical study reports.

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

UPDATED PUBLIC PARTICIPATION INFORMATION: June 10, 2024: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement

June 10, 2024; 9:00 a.m. - 5:00 p.m. ET

The public participation information has been changed for the June 10, 2024 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee.

Registration is not required.

Webinar – Final Guidance: Remanufacturing of Medical Devices

June 27, 2024; 1:00 - 2:00 p.m. ET

The purpose of this guidance is to clarify the distinction between "servicing" and "remanufacturing" of medical devices. Entities performing these activities have different regulatory responsibilities. This clarification will help ensure consistency and better understanding of the regulatory requirements applicable to remanufacturers. 

Registration is not required.

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.