Avandia Advisory Committee Re-Review Reflects Well On FDA
The FDA advisory committee re-review of cardiovascular safety risks with GlaxoSmithKline's Avandia (rosiglitazone) will not end calls from agency critics to create a separate drug safety center. However, the transparency of internal scientific disputes on display at the July 13-14 meeting and the committee's recommendations could take some ammunition away from those who assert the Center for Drug Evaluation and Research has given short shrift to safety issues
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Comforted by the re-adjudicated RECORD results, agency directs rosiglitazone sponsors to provide training “based on the current state of knowledge” about the diabetes drug’s cardiovascular risk but eliminates the requirement that links drug access to provider, pharmacy and patient enrollment in the REMS.
Wolfe steps down to become senior advisor but remains a vocal critic of the pharmaceutical industry and FDA, as his appearance at the Avandia advisory committee meeting demonstrated.
Two FDA panels will jointly review an independent “re-adjudication” of GlaxoSmithKline’s RECORD study of Avandia’s cardiovascular risk; 12 of 33 panel members voted to withdraw the drug when they considered the RECORD data in 2010.