May 31, 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 30, 2024 - FDA, USDA, EPA enhance efforts to reduce food loss and waste, welcome USAID to interagency collaborative
• May 30, 2024 - FDA’s Reorganization Approved for Establishing Unified Human Foods Program, New Model for Field Operations and Other Modernization Efforts
• May 28, 2024 - FDA Approves First Interchangeable Biosimilar for Two Rare Diseases
• May 28, 2024 - FDA Roundup
• May 24, 2024 - FDA Roundup

FDA Selects START Pilot Program Participants to Help Accelerate Development of Rare Disease Therapies

FDA is taking steps to help further accelerate the development of novel drug and biological products for rare diseases that are intended to address unmet medical needs. On May 29, 2024, FDA notified selected participants of their acceptance into the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program.

FDA Voices

Treatment Using Medication for Opioid Use Disorder Can Save Lives

Since launching our Overdose Prevention Framework in August, 2022, the FDA has taken some important steps to address the opioid overdose crisis. Today I’d like to catch up with you about opioid use disorder (OUD), and efforts we’re taking to mitigate this ongoing health condition.

OUD is a chronic health condition, which is treatable with medication in a variety of practice settings, including primary care. An estimated 6.1 million people in the U.S. aged 12 or older have OUD, which in primary care settings is often unrecognized. OUD is defined as a loss of control of opioid use, risky opioid use, and impaired social functioning. Symptoms of this disease include an overpowering desire to use opioids, increased opioid tolerance, and withdrawal syndrome when opioids are discontinued.

Guidance Documents

Platform Technology Designation Program for Drug Development

This guidance provides details about the implementation of the platform technology designation program established by section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C 16 Act).²

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.

ICYMI!

The Future of Clinical Trials, The Real Cost Campaign, and Sun Safety Tips | FDA In Your Day Ep. 5 (youtube.com)

Webinars and Virtual Workshops

Co-sponsored Public Workshop - Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle

June 26 - 27, 2024

Day 1: Wed, Jun 26; 11:00 a.m. - 3:00 p.m. ET
Day 2: Thu, Jun 27; 11:00 a.m. - 3:00 p.m. ET

The FDA is announcing a co-sponsored public workshop with the Digital Medicine Society (DiMe) titled "Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle."

Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule

June 26, 2024; 1:00 - 2:00 p.m. ET

The webinar will provide background information on prescription drug promotion, including different categories and types of promotion, as well as regulatory requirements for each. Interested parties will then learn about the CCN final rule, including the five standards associated with the rule and the rule’s compliance date. Finally, the speaker will note available FDA resources to assist firms in complying with the CCN final rule and applicable requirements for prescription drug promotion.

Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest

June 27, 2024; 9:00 a.m. - 4:00 p.m. ET

The FDA, in partnership with the Reagan-Udall Foundation for the FDA, is hosting a hybrid public meeting on “Understanding Current Use of Ketamine for Emerging Areas of Therapeutic Interest.”

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.