Beth Schurman is Partner at Herspiegel Consulting.
The Framework for FDA’s Real-World Evidence Program
A look at the scope of the agency’s draft framework for evaluating the use of RWE to support new drug approvals and the implications for sponsors.
Framework for FDA’s Real-World Evidence Program
The FDA proposes to use the RWE Program to guide generation of data in support of approval for new indications or to help support post-approval study requirements.
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