Researcher profile · Semantic Scholar

J. Shuren

h-index: 17
Works: 40
Citations: 2,965

Most-cited papers

Real-World Evidence - What Is It and What Can It Tell Us?
Rachel E. Sherman, S. Anderson, G. Dal Pan, Gerry W Gray +11 more
2016New England Journal of Medicine1,791 citations
Semantic Scholar
The safety of newly approved medicines: do recent market removals mean there is a problem?
Michael A. Friedman, J. Woodcock, M. Lumpkin, J. Shuren +2 more
1999Journal of the American Medical Association (JAMA)235 citations
Semantic Scholar
FDA Regulation of Mobile Medical Apps.
J. Shuren, Bakul Patel, S. Gottlieb
2018Journal of the American Medical Association (JAMA)146 citations
Semantic Scholar
Transforming Evidence Generation to Support Health and Health Care Decisions.
R. Califf, M. Robb, A. Bindman, Josephine P. Briggs +26 more
2016New England Journal of Medicine127 citations Open access
Semantic Scholar
An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials.
O. Faris, J. Shuren
2017New England Journal of Medicine124 citations Open access
Semantic Scholar
Need for a National Evaluation System for Health Technology.
J. Shuren, R. Califf
2016Journal of the American Medical Association (JAMA)114 citations
Semantic Scholar
Transcatheter valve therapy registry is a model for medical device innovation and surveillance.
J. Carroll, J. Shuren, T. Jensen, J. Hernandez +7 more
2015Health Affairs49 citations
Semantic Scholar
Reduced Leaflet Motion in Bioprosthetic Aortic Valves--The FDA Perspective.
J. Laschinger, Changfu Wu, Nicole G. Ibrahim, J. Shuren
2015New England Journal of Medicine46 citations Open access
Semantic Scholar
The NIH-led research response to COVID-19
Francis Collins, S. Adam, C. Colvis, E. Desrosiers +28 more
2023Science38 citations Open access
Semantic Scholar
Internet Purchase of Prescription Drugs: Buyer Beware
J. Henney, J. Shuren, S. Nightingale, T. J. McGinnis
1999Annals of Internal Medicine37 citations
Semantic Scholar
Covid-19 Molecular Diagnostic Testing - Lessons Learned.
J. Shuren, T. Stenzel
2020New England Journal of Medicine35 citations
Semantic Scholar
Advances in the Use of Real‐World Evidence for Medical Devices: An Update From the National Evaluation System for Health Technology
R. Fleurence, J. Shuren
2019Clinical pharmacology and therapy34 citations Open access
Semantic Scholar
Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States.
D. Holmes, R. Califf, A. Farb, D. Abel +5 more
2016Journal of the American College of Cardiology25 citations Open access
Semantic Scholar
The FDA's Experience with Covid-19 Antibody Tests.
J. Shuren, T. Stenzel
2021New England Journal of Medicine21 citations
Semantic Scholar
Pictorial superiority during verbal learning tasks in moderate to severe closed head injury: additional evidence.
F. Constantinidou, J. Neils, Dawn E. Bouman, Linda Lee +1 more
1996The Journal of general psychology21 citations
Semantic Scholar
Strengthening the Evidence Base for Pediatric Medical Devices Using Real-World Data.
R. Fleurence, C. Forrest, J. Shuren
2019Jornal de Pediatria19 citations Open access
Semantic Scholar
The Future of Registries in the Era of Real-world Evidence for Medical Devices
R. Fleurence, K. Blake, J. Shuren
2019JAMA cardiology17 citations
Semantic Scholar
At the Intersection of Health, Health Care and Policy
R. Kuntz, M. Mack, D. Marinac-Dabic, F. Edwards +7 more
201416 citations
Semantic Scholar
Digital Therapeutics for MCI and Alzheimer’s disease: A Regulatory Perspective — Highlights From The Clinical Trials on Alzheimer’s Disease conference (CTAD)
J. Shuren, P. M. Doraiswamy
2022The journal of prevention of Alzheimer's disease15 citations Open access
Semantic Scholar
The FDA's Role in the Development of Medical Mobile Applications
J. Shuren
2014Clinical pharmacology and therapy13 citations
Semantic Scholar
The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do We Need to Go?
D. Holmes, R. Hance, Tamara S. Syrek Jensen, Daniel A. Schwartz +7 more
2018JACC: Cardiovascular Interventions11 citations Open access
Semantic Scholar
Clinical Perspective--Early Feasibility Device Medical Studies in the United States: Time for More Than Regulatory Reform.
D. Holmes, J. Shuren, R. Califf, Bram D. Zuckerman +4 more
2016JACC: Cardiovascular Interventions10 citations Open access
Semantic Scholar
Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
J. Shuren, Brendan Bowen
200810 citations
Semantic Scholar
The FDA and genetic testing.
E. Litwack, E. Mansfield, J. Shuren
2015New England Journal of Medicine9 citations
Semantic Scholar
The Food and Drug Administration's Counterfeit Drug Initiative
Ilisa B. G. Bernstein, J. Shuren
20064 citations
Semantic Scholar
Determination of Regulatory Review Period for Purposes of Patent Extension; KETEK
J. Shuren
20062 citations
Semantic Scholar
Legal Accountability for Utilization Review in ERISA Health Plans
J. Shuren
19991 citations
Semantic Scholar
Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products—Submitting
J. Shuren
20230 citations
Semantic Scholar
US FDA publishes first report on patient-reported outcomes
J. Shuren
2018PharmacoEconomics & outcomes news0 citations
Semantic Scholar
OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs
J. Shuren, L. Luther
20160 citations
Semantic Scholar
Financing the Nation's Graduate Medical Education
J. Shuren
20110 citations
Semantic Scholar
Modernizing device regulation.
R. Kretzer, C. Foreman, J. Shuren
2010New England Journal of Medicine0 citations
Semantic Scholar
Small Entity Compliance Guide: Bottled Water: Residual Disinfectants and Disinfection Byproducts; Availability
J. Shuren
20090 citations
Semantic Scholar
National Institutes of Health Proposed Collection; Comment Request; Case-Cohort Study of Cancer and Related Disorders Among
J. Shuren
20080 citations
Semantic Scholar
Proposed Project: Patient Navigator Outreach and Chronic Disease Prevention Demonstration Program Patient Data Collection Form—NEW
J. Shuren
20080 citations
Semantic Scholar
Voluntary Third-Party Certification Programs for Imported Aquacultured Shrimp; Notice of Pilot Program
J. Shuren, Brett Koonse
20080 citations
Semantic Scholar
Notice of Submission of Proposed Information Collection to OMB; Local Appeals to Single-Family Mortgage Limits
J. Shuren
20050 citations
Semantic Scholar
Direct sale of sildenafil (Viagra) to consumers over the Internet.
J. Henney, J. Shuren
2000New England Journal of Medicine0 citations
Semantic Scholar
Safety of FDA-Approved Drugs—Reply
M. Friedman, Janet Woodcock, Murray Lumpkin, J. Shuren +2 more
1999Journal of the American Medical Association (JAMA)0 citations
Semantic Scholar
Department of Health and Human Services Food and Drug Administration 21 Cfr Parts 314 and 320 Requirements for Submission of in Vivo Bioequivalence Data; Proposed Rule
I. Background, Ii Comments, J. Shuren, Aída I Sánchez
0 citations
Semantic Scholar

R. Fleurence

×4

D. Marinac-Dabic×3

A. Farb×3

M. Leon×3

Rachel E. Sherman×2

M. Robb×2

R. Califf×2

Arthur E. Hass×2