The US Food and Drug Administration’s draft guidance on demonstrating substantial evidence of efficacy has drawn split views on the suitability of animal data to serve as confirmatory evidence, while some commenters also seek more specificity on the types of real-word data and real-world evidence that could supplement a single adequate and well-controlled trial.
Confirmatory Evidence: FDA Guidance Allowance For Use Of Animal Data Draws Split Views
Industry comments also seek more specificity on the types of real-world data that could supplement a single adequate and well-controlled trial to demonstrate substantial evidence of efficacy, and clarification as to whether confirmatory evidence can come from the same single clinical study.
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