Posted by Michael Wonder on 29 Apr 2017
Accelerating development of scientific evidence for medical products within the existing US regulatory framework
1 May 2017 - 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.
