On April 17, 2018, FDA is hosting a public meeting on Patient-Focused Drug Development for Opioid Use Disorder (OUD), in collaboration with National Institute of Drug Abuse (NIDA). In addition to NIDA, FDA is also working closely with patient advocacy and community organizations to encourage participation from individuals with OUD. This meeting aligns with FDA’s ongoing work aimed at reducing the impact of opioid abuse and addiction.
In particular, FDA is interested in learning patients’ perspectives on OUD, including the effects on their health and well-being that have the greatest impact on daily life, their experience using prescription medical treatments and other treatments or therapies for OUD, and challenges or barriers to accessing or using medical treatments for OUD.
FDA will be streaming a live audio recording of the meeting with the presentation slides, which is open to the public at: https://collaboration.fda.gov/pfdd041718/. The audio recording and presentation slides, along with a meeting transcript and summary report, will also be made publicly available after the meeting. Because of the sensitive nature of the meeting topic, and the importance of gathering candid, meaningful input from individuals who have come forward to speak about living with opioid use disorder, no other audio recording, video recording, and/or photography will be allowed at this Patient-Focused Drug Development meeting. FDA is asking for your cooperation and strongly requests that you respect the privacy of all attendees.
This website will be updated as meeting materials are developed.
Date: April 17, 2018
Time: 10:00 a.m. - 4:00 p.m. (registration begins at 9:00am)
Location: FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Room 1503A (Great Room)
Silver Spring, MD 20993
(Information about arrival to FDA’s White Oak campus)
We recommend early registration for the meeting
Public Docket: In addition to proving input at the public meeting, stakeholders are invited to provide their perspectives on the discussion questions through the public docket.
- The docket closes on June 18, 2018. FDA is interested in responses to the questions listed in the Federal Register Notice
- Public Docket Information
- OUD PFDD Meeting Agenda (PDF - 177 KB)
- Transcript (PDF - 1 MB)
- Meeting Slides (PDF - 1 MB)
- Meeting Recording 1
- Meeting Recording 2
- Meeting Recording 3
- CDER Patient Focused Drug Development
- Enhancing Benefit-Risk Assessment in Regulatory Decision-Making