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Regulatory Review Duration and Differences in Submission Times of Drugs in the United States and Europe, 2011 to 2020.

Autor: Vokinger KN; Institute of Law, University of Zurich, Zurich, Switzerland, and Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (K.N.V.)., Serra-Burriel M; Institute of Law and Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland (M.S.)., Glaus CEG; Institute of Law, University of Zurich, Zurich, Switzerland (C.E.G.G.)., Rohr UP; Swissmedic, Swiss Agency for Therapeutic Products, Bern, Switzerland (U.-P.R., S.D.T.S.)., Hwang TJ; Division of Urological Surgery, Brigham and Women's Hospital, Harvard Medical School, and Cancer Innovation and Regulation Initiative, Lank Center for Genitourinary Cancer, Boston, Massachusetts (T.J.H.)., Dalla Torre di Sanguinetto S; Swissmedic, Swiss Agency for Therapeutic Products, Bern, Switzerland (U.-P.R., S.D.T.S.)., Kesselheim AS; Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (A.S.K.).

Publikováno v: Annals of internal medicine [Ann Intern Med] 2023 Oct; Vol. 176 (10), pp. 1413-1418.