Final Generic Abuse-Deterrent Opioids Guidance Coming This Year
US FDA says it expects to finalize guidance by November, but more research is needed with generic development questions lingering.
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Gottlieb Becomes US FDA Commissioner With Immediate Issues Pending
Senate confirmation includes fewest supporting votes for any candidate ever as agency tackles budget, user fees and other issues.
Abuse-Deterrent Opioids: Postmarketing Data Eyed As Development ‘Anchor’
Panelists at US FDA advisory committee on Inspirion's RoxyBond note reservations about abuse-deterrent claims absent more real-world data on how they work; FDA's Staffa suggests agency is eager to see how well premarket work predicts postmarket experience – though the data are far from being available.
Opioid Policy At US FDA: Gottlieb Seeks More Activist Role To Combat Abuse
‘Dramatic action’ needed to curb opioid epidemic, commissioner-nominee says, including potentially a cross-center approach to evaluating drugs and devices for pain, and new nomenclature for formulations currently labeled as abuse deterrent.