Real-World Evidence Could Become Effective Tissue-Agnostic Carving Knife
The data may be different, but US FDA will consider real-world evidence to add a tissue-agnostic indication, as well as take it away.
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Biopharma industry urges agency to open the door wider to use of non-randomized observational studies to support efficacy claims, but insurer Kaiser Permanente calls such studies problematic.
Agency plans guidance on whether observational studies can provide real-world evidence to support regulatory decisions about drug effectiveness; however, RWE framework includes critical questions about retrospective studies, and reflects agency concerns about transparency.