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Nat Rev Drug Discov. 2017 May;16(5):297-298. doi: 10.1038/nrd.2017.25. Epub 2017 Feb 24.

Accelerating development of scientific evidence for medical products within the existing US regulatory framework.

Author information

1
US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, USA.
2
Duke Clinical Research Institute, 300 W Morgan Street, Durham, North Carolina 27701, USA.

Abstract

Growing access to diverse 'real-world' data sources is enabling new approaches to close persistent evidence gaps about the optimal use of medical products in real-world practice. Here, we argue that contrary to widespread impressions, existing FDA regulations embody sufficient flexibility to accommodate the emerging tools and methods needed to achieve this goal.

PMID:
28232726
DOI:
10.1038/nrd.2017.25
[Indexed for MEDLINE]

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