US FDA Officials Provide Primer On 'Real-World' Data

FDA made a commitment to explore the use of real-world evidence in evaluating the safety and effectiveness of medicines in its negotiations with the biopharmaceutical industry over the reauthorization of the Prescription Drug User Fee Act (PDUFA VI). With the enactment of legislation reauthorizing the user fee program, the agency is highlighting its focus on this issue.

In a viewpoint article in the Aug. 22/29 issue of the Journal of the American Medical Association, FDA's Jonathan Jarow, senior medical advisor to the director of the Center for...