A New Phase for Phase IV: Post-marketing Studies Won't Be the Same After Drug Safety Bill
This article was originally published in RPM Report
Executive Summary
The world of post-approval research is going to get more public, more crowded, and more dangerous to pharma. Post-marketing surveillance, transparent clinical trial results and mandated post-approval studies mean the traditional world of marketing-oriented Phase IV is about to change dramatically.
You may also be interested in...
MDUFA V: US FDA Staff Could See September Lay-Off Notices
The notices normally would go out on 1 August, but unspent user fee funds may be able to sustain work for a few weeks if the program expires.
US FDA User Fees: Lay-Off Notices Planned For Early September If Congress Doesn’t Pass Bill
The notices normally would go out on 1 August, but unspent user fee funds may be able to sustain work for a few weeks if the program expires.
US FDA User Fees: Lay-Off Notices Planned For Early September If Congress Doesn’t Pass Bill
The notices normally would go out on 1 August, but unspent user fee funds may be able to sustain work for a few weeks if the program expires.