Medical Innovation Exchange

real world evidence

FDA Seeks Input on Advancing Use of Real-World Data and Evidence

FDA Seeks Input on Advancing Use of Real-World Data and Evidence     The FDA is seeking input from stakeholders on how it should use user fee funding for engaging with external organizations, other than the National Evaluation System for Health Technology (NEST), to support premarket Real-World Evidence. Under the fifth reauthorization of the Medical Device …

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Realizing the Promise of Real-World Evidence in MedTech

Realizing the Promise of Real-World Evidence in MedTech     Ever since the U.S. Food and Drug Administration (FDA) enacted the 21st Century Cures Act in 2016 and encouraged sponsors to utilize real-world evidence (RWE) with the intent to increase innovation and accelerate product development, medical technology innovators have been eager to comply. The burgeoning use …

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