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© 2023 MJH Life Sciences and Applied Clinical Trials Online. All rights reserved.
© 2023 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.
Beth Schurman is Partner at Herspiegel Consulting.
April 01, 2019
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.
January 31, 2019
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.