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.
FDA Polled Review Staff On Avandia REMS Changes
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.