FDA Opioid REMS Meeting with Industry, May 16, 2011
On May 16, 2011, the FDA met with members of the Industry Working Group (IWG) and other sponsors of Long Acting and Extended Release opioid drugs. The purpose of the meeting was to discuss the next steps in implementing A Risk Evaluation and Mitigation Strategy (REMS) for these products through a single shared system. Topics discussed included:
- prescriber training
- Medication Guides
- REMS assessment plan
- administrative requirements
The meeting was productive and resulted in greater clarity for how drug sponsors will proceed with the opioids REMS implementation. The minutes of this meeting, along with a set of questions submitted by the IWG and responses from FDA, are posted below.
For further information, please contact: OpioidREMS@fda.hhs.gov.
- Meeting Minutes
- Preliminary Responses to Industry Questions About Opioid REMS (May 16, 2011)
- FDA Responses to Additional Industry Questions Submitted Following the May 16, 2011 Meeting (6/17/2011)