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.
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Can A REMS Mitigate CV Risks? Avandia, Meridia Offer Point, Counterpoint
As US FDA weighs fate of Takeda’s febuxostat, advisory committee members suggest REMS to ensure prescribers have informed benefit/risk conversation with patients, but agency staff highlight design and assessment challenges for such a program.
Drug Safety Meta-Analyses: US FDA Emphasizes Trial Quality Over Quantity
Three years overdue, agency draft guidance seeks to inject a threshold level of rigor into meta-analyses of randomized, controlled trials to evaluate drug safety and proposes a three-tiered hierarchy of evidence against which FDA will evaluate such studies for regulatory decision-making purposes.
FDA’s Black Box Instant Replay: A Higher Standard To Remove
Pfizer’s request for leniency on Chantix will likely be shelved, but advisory committee allows exploration of regulatory area where FDA has limited experience: The rollback of safety labeling.