Medical Innovation Exchange

Real world data

FDA Highlights Exemptions for Real World Data-identified AEs

FDA Highlights Exemptions for Real World Data-identified AEs     On December 20, the FDA updated its Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices web page to remind manufacturers that it has granted several exemptions to its Medical Device Reporting (MDR) requirements related to events identified in certain real-world data (RWD) …

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AHRQ Announces Real World Data Competition for HCOs

AHRQ Announces Real World Data Competition for HCOs     On September 27, the Agency for Healthcare Research and Quality (AHRQ) announced a new challenge competition to explore the feasibility, resources and infrastructure needed to integrate real-world healthcare system data into AHRQ’s systematic review findings to improve healthcare practice. The top award winner could earn up …

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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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