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.
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.
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.
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
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.
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."
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.
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.”
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.
May 31, 2024
