BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

135 related articles for article (PubMed ID: 28463914)

  • 1. The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.
    Barker JP; Simon SD; Dubin J
    J Bone Joint Surg Am; 2017 May; 99(9):711-719. PubMed ID: 28463914
    [TBL] [Abstract][Full Text] [Related]  

  • 2. How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?
    Samuel AM; Rathi VK; Grauer JN; Ross JS
    Clin Orthop Relat Res; 2016 Apr; 474(4):1053-68. PubMed ID: 26584802
    [TBL] [Abstract][Full Text] [Related]  

  • 3. The quality of reporting of orthopaedic randomized trials with use of a checklist for nonpharmacological therapies.
    Chan S; Bhandari M
    J Bone Joint Surg Am; 2007 Sep; 89(9):1970-8. PubMed ID: 17768194
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Analysis of FDA-Approved Orthopaedic Devices and Their Recalls.
    Day CS; Park DJ; Rozenshteyn FS; Owusu-Sarpong N; Gonzalez A
    J Bone Joint Surg Am; 2016 Mar; 98(6):517-24. PubMed ID: 26984921
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Spinal devices in the United States-investigational device exemption trials and premarket approval of class III devices.
    Golish SR; Reed ML
    Spine J; 2017 Jan; 17(1):150-157. PubMed ID: 27737804
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Orthopaedic joint devices: the FDA's short answers to your questions.
    Foy JR; Buch BD
    J Am Acad Orthop Surg; 2008; 16 Suppl 1():S123-8. PubMed ID: 18612007
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices.
    Dhruva SS; Bero LA; Redberg RF
    JAMA; 2009 Dec; 302(24):2679-85. PubMed ID: 20040556
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?
    Fox-Rawlings SR; Gottschalk LB; Doamekpor LA; Zuckerman DM
    Milbank Q; 2018 Sep; 96(3):499-529. PubMed ID: 30203600
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs.
    Golish SR
    Trials; 2017 Jul; 18(1):348. PubMed ID: 28738891
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Reporting of outcomes in orthopaedic randomized trials: does blinding of outcome assessors matter?
    Poolman RW; Struijs PA; Krips R; Sierevelt IN; Marti RK; Farrokhyar F; Bhandari M
    J Bone Joint Surg Am; 2007 Mar; 89(3):550-8. PubMed ID: 17332104
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports.
    Chang L; Dhruva SS; Chu J; Bero LA; Redberg RF
    BMJ; 2015 Jun; 350():h2613. PubMed ID: 26063311
    [TBL] [Abstract][Full Text] [Related]  

  • 12. The FDA's role in medical device clinical studies of human subjects.
    Saviola J
    J Neural Eng; 2005 Mar; 2(1):S1-4. PubMed ID: 15876645
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Incremental Revisions across the Life Span of Ophthalmic Devices after Initial Food and Drug Administration Premarket Approval, 1979-2015.
    Gopal AD; Rathi VK; Teng CC; Del Priore L; Ross JS
    Ophthalmology; 2017 Aug; 124(8):1237-1246. PubMed ID: 28501378
    [TBL] [Abstract][Full Text] [Related]  

  • 14. US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis.
    Razavi M; Glasziou P; Klocksieben FA; Ioannidis JPA; Chalmers I; Djulbegovic B
    JAMA Netw Open; 2019 Sep; 2(9):e1911111. PubMed ID: 31509209
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.
    Rathi VK; Krumholz HM; Masoudi FA; Ross JS
    JAMA; 2015 Aug; 314(6):604-12. PubMed ID: 26262798
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.
    Zheng SY; Dhruva SS; Redberg RF
    JAMA; 2017 Aug; 318(7):619-625. PubMed ID: 28810022
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Methodological reporting quality of randomized controlled trials: A survey of seven core journals of orthopaedics from Mainland China over 5 years following the CONSORT statement.
    Zhang J; Chen X; Zhu Q; Cui J; Cao L; Su J
    Orthop Traumatol Surg Res; 2016 Nov; 102(7):933-938. PubMed ID: 27514437
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Overview of the 2016 U.S. Food and Drug Administration Circulatory System Devices Advisory Panel Meeting on the Absorb Bioresorbable Vascular Scaffold System.
    Steinvil A; Rogers T; Torguson R; Waksman R
    JACC Cardiovasc Interv; 2016 Sep; 9(17):1757-64. PubMed ID: 27609249
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014.
    Rathi VK; Wang B; Ross JS; Downing NS; Kesselheim AS; Gray ST
    Otolaryngol Head Neck Surg; 2017 Feb; 156(2):285-288. PubMed ID: 28093943
    [TBL] [Abstract][Full Text] [Related]  

  • 20. FDA's perspectives on cardiovascular devices.
    Chen EA; Patel-Raman SM; O'Callaghan K; Hillebrenner MG
    J Cardiovasc Transl Res; 2009 Jun; 2(2):143-6. PubMed ID: 20559979
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.