Posted by Michael Wonder on 06 Dec 2018
Statement from FDA Commissioner on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
6 December 2018 - The health care system is integrating more effective ways to leverage electronic tools to gather and use vast amounts of health-related data.
These tools offer new opportunities to use data collected during the routine care of patients to advance medical care. Leveraging such data – typically called real-world data (RWD) - to improve regulatory decisions is a key strategic priority for the FDA.
Today, the FDA is announcing our new 2019 strategic Framework for how we’ll continue to advance these opportunities.
