FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered
FDA Law Blog
APRIL 23, 2023
This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The goal is to select similar patients in the treatment and external control groups. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.
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