Opioid REMS Revisions Reflect Some, Not All, Stakeholder Concerns
US FDA's education blueprint now asks sponsors to extend REMS to health providers beyond prescriber, but pain classifications remain unchanged.
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The US FDA has some ideas for short-term improvements in the continuing education “blueprint” used as part of the opioid class REMS. Providers want more dramatic changes to the CE model itself.
Gottlieb Leaves FDA Feeling Good About Generic Approvals, But Concerned About Innovative Competition
In interview with the Pink Sheet, US FDA Commissioner Scott Gottlieb offers a final reflection of his time as commissioner.
The advisory committee will discuss a broad range of questions on a facet of FDA's opioid strategy that has received less attention than the others.