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Behind the Scenes at Closed Sessions of FDA Advisory Committee Meetings for Abuse-Deterrent Opioids

Communicating the public health benefit of abuse-deterrent formulations (ADFs) of opioids at a Food and Drug Administration (FDA) advisory committee (ADCOM) meeting presents complexities for Sponsors of these products. One of the key challenges Sponsors face is knowing what and how to effectively communicate at the closed session, which precedes the open session of all ADCOMs for ADFs. While Sponsors can gain insights on ADCOM preparation for open sessions through publicly-available transcripts and videos, the confidential nature of closed sessions precludes this. The authors have attended most of the closed sessions for ADFs, and in this article, outline steps Sponsors can take to make the closed sessions more effective.... Read More >