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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

Medical 111
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RWE There Yet? FDA’s New Pilot Program Seeks to Help Usher in a New Era for Real World Evidence

FDA Law Blog

These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial. There will be two submission deadlines per year on March 31 and September 30, through March 31, 2027.

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5 Takeaways From Health Insurers’ New Pledge To Improve Prior Authorization

Physician's Weekly

“There’s no question that health insurers have a reputation problem,” said Robert Hartwig, an insurance expert and a clinical associate professor at the University of South Carolina. .” Health insurance CEOs now move with security details wherever they go, Klomp said. Prior authorization isn’t going anywhere.