FDA Approves "Unprecedented" Risk Management Program For Accutane
This article was originally published in The Pink Sheet Daily
Executive SummaryWholesalers, pharmacists, prescribers and patients will have added responsibility under the iPLEDGE program.
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The Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committees will assess the risk management program Dec. 1 for lessons about implementing REMS containing elements to assure safe use and selecting assessment metrics.