The Avandia REMS’ Elements To Assure Safe Use
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Eliminating MedGuide-Only REMS Merits PDUFA-Style Deadlines, PhRMA Says
FDA should take no more than three months deciding whether a Medication Guide can be pulled out of an existing Risk Evaluation and Mitigation Strategy, the Pharmaceutical Research and Manufacturers of America believes.
Eliminating MedGuide-Only REMS Merits PDUFA-Style Deadlines, PhRMA Says
FDA should take no more than three months deciding whether a Medication Guide can be pulled out of an existing Risk Evaluation and Mitigation Strategy, the Pharmaceutical Research and Manufacturers of America believes.
Avandia REMS Requires Doctors To Tell Patients About Actos’ CV Safety
The Risk Evaluation and Mitigation Strategy for GlaxoSmithKline’s Avandia (rosiglitazone) includes a prominent role for Takeda’s competing thiazolidinedione Actos (pioglitazone).