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Confirmatory Evidence: FDA Guidance Allowance For Use Of Animal Data Draws Split Views

 
• By Sue Sutter

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.

Confirmation checkmark
Industry and other stakeholders weigh in on the FDA's recent guidance on demonstrating efficacy through a single study with confirmatory evidence. • Source: Shutterstock

The US Food and Drug Administration’s draft guidance on demonstrating substantial evidence of efficacy has drawn split views on the suitability of animal data to serve as confirmatory evidence, while some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.

Released in September, the draft guidance, “Demonstrating Substantial Evidence of Effectiveness With One Adequate And Well-Controlled Clinical Investigation and Confirmatory...

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