title: Transforming Evidence Generation to Support Health and Health Care Decisions.
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Melissa A
authors.initials: MA
authors.lastname: Robb
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Andrew B
authors.initials: AB
authors.lastname: Bindman
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Josephine P
authors.initials: JP
authors.lastname: Briggs
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Francis S
authors.initials: FS
authors.lastname: Collins
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Patrick H
authors.initials: PH
authors.lastname: Conway
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Trinka S
authors.initials: TS
authors.lastname: Coster
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Francesca E
authors.initials: FE
authors.lastname: Cunningham
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Nancy
authors.initials: N
authors.lastname: De Lew
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Karen B
authors.initials: KB
authors.lastname: DeSalvo
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Christine
authors.initials: C
authors.lastname: Dymek
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Victor J
authors.initials: VJ
authors.lastname: Dzau
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Rachael L
authors.initials: RL
authors.lastname: Fleurence
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Richard G
authors.initials: RG
authors.lastname: Frank
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: J Michael
authors.initials: JM
authors.lastname: Gaziano
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Petra
authors.initials: P
authors.lastname: Kaufmann
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Michael
authors.initials: M
authors.lastname: Lauer
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Peter W
authors.initials: PW
authors.lastname: Marks
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: J Michael
authors.initials: JM
authors.lastname: McGinnis
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Chesley
authors.initials: C
authors.lastname: Richards
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Joe V
authors.initials: JV
authors.lastname: Selby
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: David J
authors.initials: DJ
authors.lastname: Shulkin
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Shuren
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Slavitt
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Scott R
authors.initials: SR
authors.lastname: Smith
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: B Vindell
authors.initials: BV
authors.lastname: Washington
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: P Jon
authors.initials: PJ
authors.lastname: White
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Janet
authors.initials: J
authors.lastname: Woodcock
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Jonathan
authors.initials: J
authors.lastname: Woodson
authors.affiliation: From the Office of the Commissioner (R.M.C., R.E.S.) and the Centers for Drug Evaluation and Research (M.A.R., J. Woodcock), Biologics Evaluation and Research (P.W.M.), and Devices and Radiological Health (J.S.), Food and Drug Administration, Silver Spring, the Office of the Director (A.B.B.) and the Center for Evidence and Practice Improvement (C.D.), Agency for Healthcare Research and Quality, Rockville, the National Center for Complementary and Integrative Health (J.P.B.), the Office of the Director (F.S.C.), and the National Center for Advancing Translational Sciences (P.K.) and Office of Extramural Research Activities (M.L.), National Institutes of Health, Bethesda, and the Centers for Medicare and Medicaid Services, Baltimore (P.H.C., A.M.S.) - all in Maryland; formerly the U.S. Army Office of the Surgeon General Pharmacovigilance Center, Falls Church, VA (T.S.C.); the Office of the Under Secretary for Health, Department of Veterans Affairs (D.J.S.), the Office of Health Policy, Office of the Assistant Secretary for Planning and Evaluation, (N.D.L., S.R.S.), the Office of the Assistant Secretary for Health (K.B.D.), and the Office of the National Coordinator for Health Information Technology (B.V.W., P.J.W.), Department of Health and Human Services, the National Academy of Medicine (V.J.D., J.M.M.), and the Patient-Centered Outcomes Research Institute (R.L.F., J.V.S.), Washington, DC; the Center for Medication Safety, Department of Veterans Affairs, Hines, IL (F.E.C.); the Department of Health Care Policy, Harvard University (R.G.F.), the Million Veteran Program, Veterans Affairs Boston Healthcare System-Division of Aging, Brigham and Women's Hospital and Harvard Medical School (J.M.G.), and the Department of Surgery, Boston University School of Medicine (J. Woodson), Boston; and the Office of Public Health Scientific Services, Centers for Disease Control and Prevention, Atlanta (C.R.).
authors.forename: Rachel E
authors.initials: RE
authors.lastname: Sherman
mesh_terms: D035843:Biomedical Research; D003657:Decision Making; D003695:Delivery of Health Care / Q000458:organization & administration*; D019317:Evidence-Based Medicine; D006291:Health Policy; D006801:Humans; D057170:Translational Research, Biomedical; D014481:United States