Real-World Evidence: Advice, Principles And Examples Emerge From FDA
Biopharma sponsors are eagerly awaiting guidance on how to apply 'real-world evidence' to drug development and regulatory decisions. Recent workshops provide some clues about what is likely to be included in the first drafts.
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FDA's Jacqueline Corrigan-Curay lists three demonstrations now underway that are aimed at looking at different aspects of generating real world evidence and may inform the agency's evaluation of the data and methods.