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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FDA advisory committee members raise concerns about inappropriate marketing and prescribing practices.
"Incremental" step forward is sufficient for product to be labeled as deterring abuse by nasal, but not intravenous route, advisory committee members conclude.
After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.