Ex-FDAer Says Real-World Data Just as Good as Clinical Data: ‘I Will Take This to the Grave’

By Shawn M. Schmitt Communications Specialist, Enzyme Call it “proving by doing”: A former Food and Drug Administration (FDA) official who led the effort to draft the US agency’s very first guidance document on real-world data says it’s imperative that pharmaceutical and medical device manufacturers shake off concerns about using RWD to support new product…