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.
You may also be interested in...
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.
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.
Aggressive staffing goals for FDA’s gene and cell therapy review group might not be fully achieved – but the head of CBER believes the new organization is on track to deliver on his high expectations going forward.