Scientific Publications by FDA Staff

Nat Rev Drug Discov 2017 May;16(5):297-8

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

Sherman RE, Davies KM, Robb MA, Hunter NL, Califf RM

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.