
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.
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.
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.
Published: February 13th 2025 | Updated: March 4th 2025
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