REMS Meeting For Opioids Shows Key Role Of Patients
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA expects to use the two-day open meeting to delve deeper into technical issues of IT and distribution that will inform further risk mitigation programs in other drug classes.
You may also be interested in...
FDA Finalizing Opioid REMS Proposal, Sets Joint Advisory Committee Meeting For July
FDA wants to gather feedback from advisors and from the public on the classwide REMS for opioid analgesics, and judging from the stakeholder meetings the agency has held so far, it will get an earful.
FDA Finalizing Opioid REMS Proposal, Sets Joint Advisory Committee Meeting For July
FDA wants to gather feedback from advisors and from the public on the classwide REMS for opioid analgesics, and judging from the stakeholder meetings the agency has held so far, it will get an earful.
REMS For Opioids Still Has A Long Road Ahead; Advisory Committee Is Likely
A finalized Risk Evaluation and Mitigation Strategy for opioids is a long way off - possibly more than a year - and FDA expects additional stakeholder and industry meetings, as well as a multidisciplinary advisory committee to take place before a program is set in stone