Avandia Day Two Might Be Same Old Song Even With Broken RECORD
This article was originally published in The Pink Sheet Daily
Executive Summary
There may be more at stake for FDA, and the pharmaceutical industry in general, in how the advisory committees interpret the RECORD trial than there is for Avandia itself.
You may also be interested in...
Sentinel Initiative Needs Better Defined Goals, Outside Review Concludes
The Pharmacovigilance Review Subcommittee of FDA's Science Board reports a lack of clarity within CDER over just what purpose the drug safety program is supposed to serve.
Sentinel Initiative Needs Better Defined Goals, Outside Review Concludes
The Pharmacovigilance Review Subcommittee of FDA's Science Board reports a lack of clarity within CDER over just what purpose the drug safety program is supposed to serve.
FDA Policy On Financial Conflicts Of Public Speakers At Advisory Panels Unchanged
In final guidance, the agency has rejected calls by the advocacy group Public Citizen to allow committee members to question open public hearing speakers on their finances.