A regulatory affairs team is considering whether to use a Real-World Evidence (RWE) study to support a label expansion. The primary regulatory challenge with RWE is:
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A
RWE studies are always more expensive than randomized controlled trials
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B
Demonstrating that the real-world data are fit for purpose and meet standards for reliability and relevance
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C
FDA does not accept any RWE for regulatory decisions
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D
RWE can only be used for rare diseases