FDA Approves "Unprecedented" Risk Management Program For Accutane
This article was originally published in The Pink Sheet Daily
Wholesalers, pharmacists, prescribers and patients will have added responsibility under the iPLEDGE program.
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The agency offers ‘regulatory flexibility’ for certain requirements of the iPLEDGE REMS for the acne drug if manufacturers address delays in implementing the modified program.
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.
FDA confirmed that it would not delay the March 1 implementation of the isotretinoin risk management program.