What Astellas Did Right In Using Real-World Evidence For Prograf Approval
US FDA’s John Concato cites rigorous collection of data and study design in getting Prograf lung transplant indication. Use of real-world evidence in Opdivo trials had mixed results, BMS exec notes.
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Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.
Despite broad interest, real-world evidence of efficacy in FDA decisions remains largely limited to orphan diseases and natural history, a Pink Sheet analysis shows.