FDA Moves Real-World Evidence Paradigm Forward With Draft Guidance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enthusiasm for increasing the use of real-world evidence to support pre-market and post-market device decisions with a draft guidance mapping out a strategy for doing so.
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The agency issued a final guidance spelling out reasonable applications of real-world device evidence and what factors must be considered when weighing whether data collected from routine care via means – such as electronic patient records or insurance claims – can help support a product approval or other regulatory decision.
Urgent calls for industry to generate and apply real world evidence were matched at a recent conference only by complaints about challenges faced by this growing, ill-defined evidence category.
FDA and industry have finally struck a tentative deal that, with Congressional approval, aims to raise nearly a billion dollars over five years. It also holds FDA to higher quality metrics while starting a pilot project to use real-world evidence in tracking devices on the market.