If FDA officials were looking for clear guidance on adequacy of the current efficacy standard for novel naloxone products, they may have walked away from an Oct. 5 advisory committee meeting disappointed.
Higher Naloxone Doses Narrowly Favored By FDA Panel
Divided advisory committee concludes the current naloxone approval standard is inadequate due in part to increase in overdoses from powerful synthetic opioids, but doesn't offer FDA a clear alternative.
