Applied Clinical Trials
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.
Beth Schurman
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Beth Schurman is Partner at Herspiegel Consulting.
Articles by Beth Schurman
Applied Clinical Trials
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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Latest Updated Articles
Framework for FDA’s Real-World Evidence ProgramJanuary 31st 2019
The Framework for FDA’s Real-World Evidence ProgramApril 1st 2019
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