A Regulatory Roadmap for Real World Evidence
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The need for real world evidence is growing beyond its original footprint of post-market intelligence, with uses now including regulatory approval, proof of value, maximized access and more. However, without a true understanding of the regulatory requirements around real world evidence, there is a risk of a “Goldilocks effect”— gathering either not enough information, the wrong information, or far more information than they need. Stuart McCully, PhD, Vice President and Tara Isherwo...
