FDA Opioid Review Adds Another Push For Advisory Committee Overhaul
External report on the US FDA’s response to the opioid epidemic includes detailed recommendations for enhancements to the advisory committee review process. That dovetails with the agency’s ongoing look at how best to use the expert panels.
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US FDA Advisory Committees' Future: Drug-Agnostic Panels, More Debate Time
FDA Commissioner Califf and some top deputies are angling for more advisory panels that would influence drug development programs rather than approval decisions. Califf also wants to adjust meeting formats so advisors have more time for in-depth discussions.
Opioid Approval Standards Could Change Under New US FDA Plan
The Overdose Prevention Framework includes considering whether FDA should require new opioids show superior safety compared to existing products.
Califf And Advisory Committees: Will He Push For Reforms?
Confirmation hearing comment suggests FDA Commissioner nominee Robert Califf thinks an overwhelming advisory committee vote should give agency officials pause.