Ladies & Gentlemen of the Jury...I Mean Advisory Committee
This article was originally published in RPM Report
Executive Summary
When King Pharmaceuticals Inc. Chief Scientific Officer Eric Carter concluded his presentation during the April 22 advisory committee review of the novel oxycodone/niacin formulation Remoxy, he sounded almost like an attorney making a closing argument before a jury.
You may also be interested in...
A Painful Decision for King and Acura
An FDA advisory committee rejects the idea of adding niacin to abusable drugs in order to provoke a flushing reaction and thereby discourage abuse. King and Acura respond by flushing the idea itself and focusing on physical barriers to abusability. For other sponsors, King's failed attempt to change FDA's mind looks like a study in what not to do.
Is The Opioid REMS Too Big To Study?
US FDA’s workshop to discuss new ideas to assess the impact of the opioid REMS comes after the industry collaboration behind the REMS has deemed the task essentially impossible.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: