The Food and Drug Administration is ramping up its efforts to leverage billing, claims, EHR and registry data to better inform the agency’s regulatory decisions regarding drugs and other medical products.
This real-world evidence (RWE) could help to “answer questions that are relevant to broader patient populations or treatment settings where information may not be captured through traditional clinical trials,” according to FDA Commissioner Scott Gottlieb, MD.
“We are expanding our ability to use RWE for post-marketing safety surveillance, and exploring its potential to help support expanded label indications,” wrote Gottlieb in an August 29 blog post.
