Getting Organized on Abuse-Deterrent Opioids: FDA Calls For Volunteers Ahead of Oct. 30-31 Meeting
This article was originally published in RPM Report
FDA is planning a two-day workshop on issues related to abuse-deterrent opioid formulations, and wants to hear unified presentations from the brand and generic industry. That is easier said than done.
You may also be interested in...
Pfizer got its first abuse-deterrent claim for its pain therapy Embeda. But it has also ended an agreement to develop another potential abuse-deterrent pain drug.
Congressional appropriators are urging FDA to move quickly to finalize guidance on abuse deterrence claims for opioids—and to take the next step and prohibit marketing of products that don’t deter abuse. FDA says the science isn’t there yet, and two sponsors join the list of those who have failed to clear the hurdle.
US FDA’s Accelerated Approval process has always been a deceptively simple idea. After a three-day public review of ‘dangling’ applications, the underlying complexity remains.