The FDA has signaled that it will take a much more welcoming approach to the use of real-world data (RWD) and real-world evidence (RWE) in decision making regarding the approval of new drugs and biologics, with the release of a new framework for the regulatory use of such evidence.
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FDA Framework Signals Openness to Real-World Evidence for Drug Approvals
The FDA has signaled that it will take a much more welcoming approach to the use of real-world data (RWD) and real-world evidence (RWE) in decision making regarding the approval of new drugs and biologics, with the release of a new framework for the regulatory use of such evidence.