FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered
FDA Law Blog
APRIL 23, 2023
Notably, the Draft Guidance states that it is not intended to address other types of external controls, such as using summary-level estimates instead of patient-level data, nor does it discuss the use of external control data to supplement a control arm in a traditional randomized controlled clinical trial.
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