FDA outlines framework for boosting use of real-world evidence

The US Food and Drug Administration has issued a statement detailing a new strategic framework to promote the use of real-world evidence (RWE) and real-world data (RWD) in the drug development process.

In the statement, FDA Commissioner Scott Gottlieb noted that RWD and RWE can be especially useful for postmarket monitoring for safety.

Under the 21st Century Cures Act, signed in 2016, the agency is required to release a comprehensive plan on how drugmakers may make use of these alternative sources of data to support regulatory filings to extend the label for an approved therapy.