Keeping Track: Neurology And Pain Products Keep FDA Occupied
Executive Summary
The latest drug development news and highlights from our FDA Performance Tracker.
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Keeping Track: So. Much. News.
The latest drug development news and highlights from our US FDA Performance Tracker.
OxyContin Repeat? US FDA Seeks To Avoid Fallout Over Butrans Pediatric Data
Advisory committees will discuss whether data from a 41-patient study should be added to Pediatric Use section of labeling for Purdue's buprenorphine product; agency's decision to convene expert panel even though a pediatric indication is not being considered grew out of criticism generated by approval of OxyContin for adolescents.
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.