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

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


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.

MeSH terms

  • Clinical Trials as Topic / methods*
  • Drug Design*
  • Drug and Narcotic Control*
  • Humans
  • Time Factors
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence*