Posted by Michael Wonder on 09 Jul 2019
FDA leverages private sector technology-based tools in its embrace of real world evidence
9 July 2019 - Following decades of near total reliance on randomised clinical trial data, the U.S. FDA (with a helpful nudge from the Congress) is accessing private sector technology-based tools as a means of incorporating real world data and evidence into its drug approval, label expansion and regulatory oversight tasks.
The agency has signalled its apparent change of heart with speeches, policy guidance, and now with two public-private partnerships: the recent expansion of its agreement with Flatiron Health, and a brand new collaboration with COTA Healthcare.
