Waivers For Shared REMS Will Depend On Impact To Generics, Docs, Patients
US FDA will take multiple factors into account when deciding whether single shared-system REMS requirement is necessary.
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Gottlieb Leaves FDA Feeling Good About Generic Approvals, But Concerned About Innovative Competition
In interview with the Pink Sheet, US FDA Commissioner Scott Gottlieb offers a final reflection of his time as commissioner.
How Do You Know If A REMS Is Effective? Look At Postmarket Data, Surveys, Patient Access
US FDA draft guidance describes how to determine if a Risk Evaluation and Mitigation Strategy is meeting its goals; another guidance advises how to conduct REMS knowledge surveys.
Will CBO Score CREATE Momentum For Generic Bill's Passage?
Strong savings estimate – and brand pharma's need to have pay-fors for its own legislative priorities – could finally get bill allowing generic companies to sue brand sponsors for access to samples.