Real-world data will likely play a bigger 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 will further expand use of these sources through the release of two new draft guidances and a partnership to rapidly assess Covid-19 products.
“The pandemic has highlighted the value of real world evidence, both for what it can tell you ...