FDA Reveals Data Modernization Action Plan Including RWD Details

The FDA released DMAP (a Data Modernization Action Plan) in response to changes and trends in the pharma industry. Some of these trends, such as the use of RWD (real world data) have been hastened by the COVID-19 pandemic. DMAP contains three major goals and is meant to help experts in the industry avoid common pitfalls.

“One key focus will be use of predictive models and artificial intelligence, as well as projects that address traditional performance indicators. For each project, FDA plans to measure and communicate the value of the initiative to internal and external stakeholders. An example FDA gave is the agency’s participation in the public-private COVID-19 Evidence Accelerator, which gathers real-world data to guide the response to the pandemic.” Read more here.

(Source: Nick Paul Taylor, Healthcare Dive, 3/4/21)