Real-World Evidence — Where Are We Now?

Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.

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Veröffentlicht in:The New England journal of medicine 2022-05, Vol.386 (18), p.1680-1682
Hauptverfasser: Concato, John, Corrigan-Curay, Jacqueline
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container_title The New England journal of medicine
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creator Concato, John
Corrigan-Curay, Jacqueline
description Notwithstanding ongoing confusion over the concepts of “real-world data” and “real-world evidence” in 2022, more than 5 years after the passage of the 21st Century Cures Act, the FDA continues to evaluate such data and evidence as it considers regulatory decisions.
doi_str_mv 10.1056/NEJMp2200089
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source Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; New England Journal of Medicine
subjects and the FDA
Clinical Medicine
Clinical Medicine General
Comparative Effectiveness
COVID-19
Devices
Drugs
Electronic health records
FDA approval
Health Policy
Product development
title Real-World Evidence — Where Are We Now?
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