A recent article published on Aetion looks at three recent decisions by the Food and Drug Administration (FDA) that included real-world evidence.
The article outlines how RWE supported the approval of Pretomanid, Zolgensma and Lutathera.
“The U.S. Food and Drug Administration (FDA) is approving more drugs with the help of real-world evidence (RWE) than ever before,” the article states. “Between 1995 and 1997, 19.4 percent of the FDA’s approvals came from having one adequate and well-controlled study plus confirmatory evidence, such as RWE. Between 2015 and 2017, that figure jumped to 47.2 percent.”
To read the full article on Aetion’s site, click here.