共 8 条
[1]
[Anonymous], Federal Register -
[2]
Berkrot B., HEART DEVICE APPROVA
[3]
Integrating quality into the cycle of therapeutic development
[J].
Califf, RM
;
Peterson, ED
;
Gibbons, RJ
;
Garson, A
;
Brindis, RG
;
Beller, GA
;
Smith, SC
.
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY,
2002, 40 (11)
:1895-1901

Califf, RM
论文数: 0 引用数: 0
h-index: 0
机构: Duke Clin Res Inst, Durham, NC 27710 USA

论文数: 引用数:
h-index:
机构:

Gibbons, RJ
论文数: 0 引用数: 0
h-index: 0
机构: Duke Clin Res Inst, Durham, NC 27710 USA

Garson, A
论文数: 0 引用数: 0
h-index: 0
机构: Duke Clin Res Inst, Durham, NC 27710 USA

Brindis, RG
论文数: 0 引用数: 0
h-index: 0
机构: Duke Clin Res Inst, Durham, NC 27710 USA

Beller, GA
论文数: 0 引用数: 0
h-index: 0
机构: Duke Clin Res Inst, Durham, NC 27710 USA

Smith, SC
论文数: 0 引用数: 0
h-index: 0
机构: Duke Clin Res Inst, Durham, NC 27710 USA
[4]
Transforming Evidence Generation to Support Health and Health Care Decisions
[J].
Califf, Robert M.
;
Robb, Melissa A.
;
Bindman, Andrew B.
;
Briggs, Josephine P.
;
Collins, Francis S.
;
Conway, Patrick H.
;
Coster, Trinka S.
;
Cunningham, Francesca E.
;
De Lew, Nancy
;
DeSalvo, Karen B.
;
Dymek, Christine
;
Dzau, Victor J.
;
Fleurence, Rachael L.
;
Frank, Richard G.
;
Gaziano, Michael
;
Kaufmann, Petra
;
Lauer, Michael
;
Marks, Peter W.
;
McGinnis, J. Michael
;
Richards, Chesley
;
Selby, Joe V.
;
Shulkin, David J.
;
Shuren, Jeffrey
;
Slavitt, Andrew M.
;
Smith, Scott R.
;
Washington, B. Vindell
;
White, P. Jon
;
Woodcock, Janet
;
Woodson, Jonathan
;
Sherman, Rachel E.
.
NEW ENGLAND JOURNAL OF MEDICINE,
2016, 375 (24)
:2395-2400

Califf, Robert M.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Commissioner, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Robb, Melissa A.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Bindman, Andrew B.
论文数: 0 引用数: 0
h-index: 0
机构:
Agcy Healthcare Res & Qual, Off Director, Rockville, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Briggs, Josephine P.
论文数: 0 引用数: 0
h-index: 0
机构:
NIH, Natl Ctr Complementary & Integrat Hlth, Bldg 10, Bethesda, MD 20892 USA US FDA, Off Commissioner, Silver Spring, MD USA

Collins, Francis S.
论文数: 0 引用数: 0
h-index: 0
机构:
NIH, Off Director, Bldg 10, Bethesda, MD 20892 USA US FDA, Off Commissioner, Silver Spring, MD USA

Conway, Patrick H.
论文数: 0 引用数: 0
h-index: 0
机构:
Ctr Medicare & Medicaid Serv, Baltimore, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Coster, Trinka S.
论文数: 0 引用数: 0
h-index: 0
机构:
US Army, Off Surg Gen Pharmacovigilance Ctr, Falls Church, VA USA US FDA, Off Commissioner, Silver Spring, MD USA

Cunningham, Francesca E.
论文数: 0 引用数: 0
h-index: 0
机构:
Dept Vet Affairs, Ctr Medicat Safety, Hines, IL USA US FDA, Off Commissioner, Silver Spring, MD USA

De Lew, Nancy
论文数: 0 引用数: 0
h-index: 0
机构:
Off Assistant Secretary Planning & Evaluat, Off Hlth Policy, Washington, DC USA US FDA, Off Commissioner, Silver Spring, MD USA

DeSalvo, Karen B.
论文数: 0 引用数: 0
h-index: 0
机构:
Off Assistant Secretary Planning & Evaluat, Off Hlth Policy, Washington, DC USA
Off Assistant Secretary Hlth, Washington, DC USA US FDA, Off Commissioner, Silver Spring, MD USA

Dymek, Christine
论文数: 0 引用数: 0
h-index: 0
机构:
Agcy Healthcare Res & Qual, Ctr Evidence & Practice Improvement, Rockville, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Dzau, Victor J.
论文数: 0 引用数: 0
h-index: 0
机构:
Natl Acad Med, Dept Hlth & Human Serv, Washington, DC USA US FDA, Off Commissioner, Silver Spring, MD USA

Fleurence, Rachael L.
论文数: 0 引用数: 0
h-index: 0
机构:
Patient Centered Outcomes Res Inst, Washington, DC USA US FDA, Off Commissioner, Silver Spring, MD USA

Frank, Richard G.
论文数: 0 引用数: 0
h-index: 0
机构:
Harvard Univ, Dept Hlth Care Policy, Boston, MA 02115 USA US FDA, Off Commissioner, Silver Spring, MD USA

Gaziano, Michael
论文数: 0 引用数: 0
h-index: 0
机构: US FDA, Off Commissioner, Silver Spring, MD USA

Kaufmann, Petra
论文数: 0 引用数: 0
h-index: 0
机构:
NIH, Natl Ctr Adv Translat Sci, Bldg 10, Bethesda, MD 20892 USA US FDA, Off Commissioner, Silver Spring, MD USA

Lauer, Michael
论文数: 0 引用数: 0
h-index: 0
机构:
NIH, Off Extramural Res Act, Bldg 10, Bethesda, MD 20892 USA US FDA, Off Commissioner, Silver Spring, MD USA

Marks, Peter W.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Biol Evaluat & Res, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

McGinnis, J. Michael
论文数: 0 引用数: 0
h-index: 0
机构:
Natl Acad Med, Dept Hlth & Human Serv, Washington, DC USA
Brigham & Womens Hosp, Div Aging, Mill Veteran Program, Vet Affairs Boston Healthcare Syst, Boston, MA 02115 USA
Harvard Med Sch, Boston, MA USA US FDA, Off Commissioner, Silver Spring, MD USA

Richards, Chesley
论文数: 0 引用数: 0
h-index: 0
机构:
Ctr Dis Control & Prevent, Off Publ Hlth Sci Serv, Atlanta, GA USA US FDA, Off Commissioner, Silver Spring, MD USA

Selby, Joe V.
论文数: 0 引用数: 0
h-index: 0
机构:
Patient Centered Outcomes Res Inst, Washington, DC USA US FDA, Off Commissioner, Silver Spring, MD USA

Shulkin, David J.
论文数: 0 引用数: 0
h-index: 0
机构:
Dept Vet Affairs, Off Secretary Hlth, Washington, DC USA US FDA, Off Commissioner, Silver Spring, MD USA

Shuren, Jeffrey
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Devices & Radiol Hlth, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Slavitt, Andrew M.
论文数: 0 引用数: 0
h-index: 0
机构:
Ctr Medicare & Medicaid Serv, Baltimore, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Smith, Scott R.
论文数: 0 引用数: 0
h-index: 0
机构: US FDA, Off Commissioner, Silver Spring, MD USA

Washington, B. Vindell
论文数: 0 引用数: 0
h-index: 0
机构:
Off Natl Coordinator Hlth Informat Technol, Washington, DC USA US FDA, Off Commissioner, Silver Spring, MD USA

White, P. Jon
论文数: 0 引用数: 0
h-index: 0
机构:
Off Natl Coordinator Hlth Informat Technol, Washington, DC USA US FDA, Off Commissioner, Silver Spring, MD USA

Woodcock, Janet
论文数: 0 引用数: 0
h-index: 0
机构: US FDA, Off Commissioner, Silver Spring, MD USA

Woodson, Jonathan
论文数: 0 引用数: 0
h-index: 0
机构:
Boston Univ, Sch Med, Dept Surg, Boston, MA 02118 USA US FDA, Off Commissioner, Silver Spring, MD USA

Sherman, Rachel E.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Commissioner, Silver Spring, MD USA
US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA
[5]
Trends and Outcomes of Off-label Use of Transcatheter Aortic Valve Replacement Insights From the NCDR STS/ACC TVT Registry
[J].
Hira, Ravi S.
;
Vemulapalli, Sreekanth
;
Li, Zhuokai
;
McCabe, James M.
;
Rumsfeld, John S.
;
Kapadia, Samir R.
;
Alam, Mahboob
;
Jneid, Hani
;
Don, Creighton
;
Reisman, Mark
;
Virani, Salim S.
;
Kleiman, Neal S.
.
JAMA CARDIOLOGY,
2017, 2 (08)
:846-854

Hira, Ravi S.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA

Vemulapalli, Sreekanth
论文数: 0 引用数: 0
h-index: 0
机构:
Duke Clin Res Inst, Durham, NC USA Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA

Li, Zhuokai
论文数: 0 引用数: 0
h-index: 0
机构:
Duke Clin Res Inst, Durham, NC USA Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA

McCabe, James M.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA

Rumsfeld, John S.
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Colorado, Sch Med, Aurora, CO USA Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA

Kapadia, Samir R.
论文数: 0 引用数: 0
h-index: 0
机构:
Cleveland Clin, Cleveland, OH 44106 USA Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA

Alam, Mahboob
论文数: 0 引用数: 0
h-index: 0
机构:
Michael E DeBakey VA Med Ctr, Houston, TX USA Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA

Jneid, Hani
论文数: 0 引用数: 0
h-index: 0
机构:
Michael E DeBakey VA Med Ctr, Houston, TX USA
Baylor Coll Med, Houston, TX 77030 USA Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA

论文数: 引用数:
h-index:
机构:

Reisman, Mark
论文数: 0 引用数: 0
h-index: 0
机构:
Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA

Virani, Salim S.
论文数: 0 引用数: 0
h-index: 0
机构:
Michael E DeBakey VA Med Ctr, Houston, TX USA
Baylor Coll Med, Houston, TX 77030 USA
Houston Methodist DeBakey Heart & Vasc Ctr, Houston, TX USA Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA

Kleiman, Neal S.
论文数: 0 引用数: 0
h-index: 0
机构:
Houston Methodist DeBakey Heart & Vasc Ctr, Houston, TX USA
Weill Cornell Med Coll, New York, NY USA Univ Washington, Cardiol Sect, 325 Ninth Ave,Box 359748, Seattle, WA 98104 USA
[6]
Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States
[J].
Holmes, David R., Jr.
;
Califf, Robert
;
Farb, Andrew
;
Abel, Dorothy
;
Mack, Michael
;
Jensen, Tamara Syrek
;
Zuckerman, Bram
;
Leon, Martin
;
Shuren, Jeff
.
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY,
2016, 68 (17)
:1908-1915

Holmes, David R., Jr.
论文数: 0 引用数: 0
h-index: 0
机构:
Mayo Clin, Dept Cardiol, Rochester, MN USA Mayo Clin, Dept Cardiol, Rochester, MN USA

Califf, Robert
论文数: 0 引用数: 0
h-index: 0
机构:
Food & Drug Adm, Silver Spring, MD USA Mayo Clin, Dept Cardiol, Rochester, MN USA

Farb, Andrew
论文数: 0 引用数: 0
h-index: 0
机构:
Food & Drug Adm, Silver Spring, MD USA Mayo Clin, Dept Cardiol, Rochester, MN USA

Abel, Dorothy
论文数: 0 引用数: 0
h-index: 0
机构:
Food & Drug Adm, Silver Spring, MD USA Mayo Clin, Dept Cardiol, Rochester, MN USA

Mack, Michael
论文数: 0 引用数: 0
h-index: 0
机构:
Baylor Scott & White Hlth, Plano, TX USA Mayo Clin, Dept Cardiol, Rochester, MN USA

Jensen, Tamara Syrek
论文数: 0 引用数: 0
h-index: 0
机构:
Ctr Medicare & Medicaid Serv, Baltimore, MD USA Mayo Clin, Dept Cardiol, Rochester, MN USA

Zuckerman, Bram
论文数: 0 引用数: 0
h-index: 0
机构:
Food & Drug Adm, Silver Spring, MD USA Mayo Clin, Dept Cardiol, Rochester, MN USA

Leon, Martin
论文数: 0 引用数: 0
h-index: 0
机构:
Columbia Univ, Med Ctr, Ctr Intervent Vasc Therapy, New York, NY USA Mayo Clin, Dept Cardiol, Rochester, MN USA

Shuren, Jeff
论文数: 0 引用数: 0
h-index: 0
机构:
Food & Drug Adm, Silver Spring, MD USA Mayo Clin, Dept Cardiol, Rochester, MN USA
[7]
Real-World Evidence - What Is It and What Can It Tell Us?
[J].
Sherman, Rachel E.
;
Anderson, Steven A.
;
Dal Pan, Gerald J.
;
Gray, Gerry W.
;
Gross, Thomas
;
Hunter, Nina L.
;
LaVange, Lisa
;
Marinac-Dabic, Danica
;
Marks, Peter W.
;
Robb, Melissa A.
;
Shuren, Jeffrey
;
Temple, Robert
;
Woodcock, Janet
;
Yue, Lilly Q.
;
Califf, Robert M.
.
NEW ENGLAND JOURNAL OF MEDICINE,
2016, 375 (23)
:2293-2297

Sherman, Rachel E.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Commissioner, Silver Spring, MD USA
US FDA, Off Biostat & Epidemiol, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Anderson, Steven A.
论文数: 0 引用数: 0
h-index: 0
机构: US FDA, Off Commissioner, Silver Spring, MD USA

Dal Pan, Gerald J.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Ctr Biol Evaluat & Res, Off Surveillance & Epidemiol, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Gray, Gerry W.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA
US FDA, Div Biostat, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Gross, Thomas
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Surveillance & Biometr, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Hunter, Nina L.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Commissioner, Silver Spring, MD USA
US FDA, Off Biostat & Epidemiol, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

LaVange, Lisa
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Biostat, Off Translat Sci, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Marinac-Dabic, Danica
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Div Epidemiol, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Marks, Peter W.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Ctr Director, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Robb, Melissa A.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Med Policy, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Shuren, Jeffrey
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Ctr Devices & Radiol Hlth, Off Ctr Director, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Temple, Robert
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Ctr Director, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Woodcock, Janet
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Ctr Director, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Yue, Lilly Q.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA
US FDA, Div Biostat, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA

Califf, Robert M.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Off Commissioner, Silver Spring, MD USA
US FDA, Off Biostat & Epidemiol, Silver Spring, MD USA US FDA, Off Commissioner, Silver Spring, MD USA
[8]
Need for a National Evaluation System for Health Technology
[J].
Shuren, Jeffrey
;
Califf, Robert M.
.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION,
2016, 316 (11)
:1153-1154

Shuren, Jeffrey
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Silver Spring, MD USA US FDA, Silver Spring, MD USA

Califf, Robert M.
论文数: 0 引用数: 0
h-index: 0
机构:
US FDA, Silver Spring, MD USA US FDA, Silver Spring, MD USA