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FDA Polled Review Staff On Avandia REMS Changes

 
• By Sue Sutter

Decision to replace the rosiglitazone REMS’ distribution restrictions with prescriber training reflected a consensus opinion shared by leadership in three CDER offices, despite a poll of reviewers who participated in a June advisory committee meeting and favored eliminating the risk management program.

FDA opted to modify the Risk Evaluation and Mitigation Strategy for GlaxoSmithKline PLC’s Avandia and other rosiglitazone-containing medicines despite an internal poll of review staff that showed a preference for eliminating the risk management program altogether.

Five of 11 FDA reviewers across a variety of disciplines favored removing the existing REMS with elements to assure safe...

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