‘Real World’ Opioid Abuse Data On OxyContin Again Under Review At US FDA
Resubmission comes more than four years after Purdue pulled an sNDA seeking to demonstrate ‘real-world’ abuse prevention.
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Five years after an advisory committee meeting was cancelled, panel will consider whether required postmarketing studies show Purdue’s reformulated opioid ‘meaningfully’ reduces abuse and overdose.
US FDA says it is preparing to hold ‘virtual’ advisory committee meetings amid the COVID-19 outbreak. Does anyone want to go first?
US FDA will survey health care providers’ current understanding of analgesic abuse-deterrent formulations and conduct an experimental study exploring the effectiveness of different terminology and descriptions for such products; agency has heard complaints from its own AdComms about terminology around abuse deterrence.