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Waivers For Shared REMS Will Depend On Impact To Generics, Docs, Patients

 
• By Derrick Gingery

US FDA will take multiple factors into account when deciding whether single shared-system REMS requirement is necessary.

The US FDA will consider several factors when considering whether to grant a waiver of the single shared system Risk Evaluation and Mitigation Strategy requirement for a generic drug sponsor, including the impact a separate system could have on generic entry.

Draft guidance issued May 31 also outlines what ANDA sponsors should include in a waiver request, but FDA made clear that it could act alone in granting a waiver. The...

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