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FDA Moves Real-World Evidence Paradigm Forward With Draft Guidance

The US agency has followed its public enthusiasm for increasing the use of real-world evidence to support pre-market and post-market device decisions with a draft guidance mapping out a strategy for doing so.

US FDA issued a draft guidance July 27 that the agency hopes will spur use of real-world evidence (RWE) and real-world data (RWD).

The guidelines, on how the agency plans to incorporate RWD into regulatory decision-making, comes as FDA has been championing the...

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