Providers Embrace US FDA REMS Integration Plan But Wary Of Another iPledge ‘Failure’
Providers are eager for the FDA to test integrating REMS requirements into electronic health records, but want the agency to ‘go slowly’ to avoid any disruptions along the way. Recent issues with two of the original restricted distribution plans in the US underscore the message of caution.
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Isotretinoin iPLEDGE REMS Proposed Revisions To Get Two-Day AdComm Review
US FDA is once again considering changes to the Risk Evaluation and Mitigation Strategy for the acne medication, a year after modifications to the program caused disruptions in patient access.
US FDA Asks Manufacturers To Fix Disruption In Isotretinoin REMS
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.
A Milestone Moment For Pharmacogenomics: US FDA Ready To Drop ‘Voluntary’ Program
The US FDA’s plan to update a 20-year-old guidance on pharmacogenomic data submissions is a good time to reflect on the dramatic transformation of industry attitudes and approaches to targeted medicine over the past two decades.