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...
FDA Opens Up: Can Industry Live With Greater Transparency?
Drug sponsors are finding little to like about FDA's transparency initiative-especially proposals that would allow the agency to disclose more about products still in development. But given the public interest in greater transparency-and FDA's interest in avoiding another Avandia-industry needs to decide whether this is a fight worth having.
FDA Opens Up: Can Industry Live With Greater Transparency?
Drug sponsors are finding little to like about FDA’s transparency initiative - especially proposals that would allow the agency to disclose more about products still in development. But given the public interest in greater transparency - and FDA’s interest in avoiding another Avandia - industry needs to decide whether this is a fight worth having. This article was originally published in the July/August 2010 issue of The RPM Report.
FDA Opens Up: Can Industry Live With Greater Transparency?
Drug sponsors are finding little to like about FDA's transparency initiative-especially proposals that would allow the agency to disclose more about products still in development. But given the public interest in greater transparency-and FDA's interest in avoiding another Avandia-industry needs to decide whether this is a fight worth having.
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