Real-world data will likely play a more significant role in FDA drug reviews as the agency adopts lessons from Covid-19 to future regulatory decisions.
The urgency of the pandemic has propelled U.S. health leaders to use data from sources such as patient medical records and mobile devices to help make decisions in real-time. The Food and Drug Administration signaled it would further expand the use of these sources through the release of two new draft guidances and a partnership to assess products rapidly.
