Real-World Evidence - What Is It and What Can It Tell Us?

Rachel E Sherman¹, Steven A Anderson¹, Gerald J Dal Pan¹+12

• ¹From the Office of the Commissioner (R.E.S., N.L.H., R.M.C.); the Office of Biostatistics and Epidemiology (S.A.A.) and the Office of the Center Director (P.W.M.), Center for Biologics Evaluation and Research; the Office of Surveillance and Epidemiology (G.J.D.P.), the Office of Biostatistics, the Office of Translational Sciences (L.L.), the Office of Medical Policy (M.A.R.), the Office of the Center Director (R.T., J.W.), Center for Drug Evaluation and Research, and the Division of Biostatistics (G.W.G., L.Q.Y.); and the Division of Epidemiology (D.M.-D.), Office of Surveillance and Biometrics (T.G.); and the Office of the Center Director (J.S.), Center for Devices and Radiological Health - all at the Food and Drug Administration, Silver Spring, MD.