FDA releases real-world evidence framework

FDA is creating a roadmap that will facilitate the integration of real-world evidence into drug development. FDA’s framework for real-world evidence envisions using data from electronic health records (EHRs), observational and pragmatic studies, and mobile or wearable devices to generate effectiveness data that would support approvals of new indications for approved drugs, and for satisfying postapproval study requirements.

Under the framework, real-world evidence (RWE) could be used to add or modify an indication, including by changing doses, dose regimens, or route of administration; or to update a label with a new population or data on comparative effectiveness or safety...