US FDA Launches Study Of Prescriber Perceptions About Abuse-Deterrent Opioids
The agency is assessing whether to use different language to describe addiction and abuse deterrence.
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Unintended Consequences Of Broad Opioid-Sparing Claims Worries US Panel
FDA advisory committee members raise concerns about inappropriate marketing and prescribing practices.
Mallinckrodt's Abuse Deterrent Oxycodone IR Narrowly Wins US FDA Panel Backing
"Incremental" step forward is sufficient for product to be labeled as deterring abuse by nasal, but not intravenous route, advisory committee members conclude.
Device Component Of Intarcia’s Diabetes Treatment ITCA 650 Worries FDA
If FDA chief scientist grants Intarcia’s request for advisory committee meeting, CDER wants to provide input on issues to be considered. Director Cavazzoni says the novel drug-device combination product does not notify the user of a critical failure or infusion status.