BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

124 related articles for article (PubMed ID: 35765256)

  • 1. An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period.
    Saxena U; Bose D; Saha S; Gogtay NJ; Thatte UM
    Indian J Med Ethics; 2022; VII(2):108-113. PubMed ID: 35765256
    [TBL] [Abstract][Full Text] [Related]  

  • 2. A study of warning letters issued to clinical investigators and institutional review boards by the United States Food and Drug Administration.
    Gogtay NJ; Doshi BM; Kannan S; Thatte U
    Indian J Med Ethics; 2011; 8(4):211-4. PubMed ID: 22106658
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study.
    Shetty YC; Saiyed AA
    J Med Ethics; 2015 May; 41(5):398-403. PubMed ID: 24965716
    [TBL] [Abstract][Full Text] [Related]  

  • 4. A study of warning letters issued to institutional review boards by the United States Food and Drug Administration.
    Bramstedt KA; Kassimatis K
    Clin Invest Med; 2004 Dec; 27(6):316-23. PubMed ID: 15675112
    [TBL] [Abstract][Full Text] [Related]  

  • 5. A study of warning letters issued to clinical investigators by the United States Food and Drug Administration.
    Bramstedt KA
    Clin Invest Med; 2004 Jun; 27(3):129-34. PubMed ID: 15305804
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Data Integrity in the Pharmaceutical Industry: Analysis of Inspections and Warning Letters Issued by the Bioresearch Monitoring Program Between Fiscal Years 2007-2018.
    Rogers CA; Ahearn JD; Bartlett MG
    Ther Innov Regul Sci; 2020 Sep; 54(5):1123-1133. PubMed ID: 32096103
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Warning letters to sponsor-investigators at academic health centres - the regulatory "canaries in a coal mine".
    O'Reilly EK; Blair Holbein ME; Berglund JP; Parrish AB; Roth MT; Burnett BK
    Clin Invest Med; 2013 Dec; 36(6):E290-6. PubMed ID: 24309225
    [TBL] [Abstract][Full Text] [Related]  

  • 8. An Updated Review of Food and Drug Administration Warning and Untitled Letters for Clinical Outcome Assessment Claims Between 2013 and 2021.
    Sams L; Slagle AF; Symonds T; Antonova J; Globe D
    Value Health; 2023 Dec; 26(12):1675-1680. PubMed ID: 37748736
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Content Analysis of 2012-2019 FDA Warning Letters and Notices of Violations using the Economic, Clinical, and Humanistic Outcomes (ECHO) Model.
    Mohite N; Funtanilla V; Muzumdar J; Park T
    Innov Pharm; 2021; 12(1):. PubMed ID: 34007685
    [TBL] [Abstract][Full Text] [Related]  

  • 10. A Retrospective Analysis of Clinical Research Misconduct Using FDA-Issued Warning Letters and Clinical Investigator Inspection List From 2010 to 2014.
    Romano CA; Nair S; Delphin ES
    Anesth Analg; 2018 Mar; 126(3):976-982. PubMed ID: 29239950
    [TBL] [Abstract][Full Text] [Related]  

  • 11. A review of FDA warning letters and notices of violation issued for patient-reported outcomes promotional claims between 2006 and 2012.
    Symonds T; Hackford C; Abraham L
    Value Health; 2014 Jun; 17(4):433-7. PubMed ID: 24969004
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Direct-to-physician and direct-to-consumer advertising: Time to have stringent regulations.
    Kannan S; Gowri S; Tyagi V; Kohli S; Jain R; Kapil P; Bhardwaj A
    Int J Risk Saf Med; 2015; 27(2):77-83. PubMed ID: 26410010
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Content Analysis of US FDA Warning Letters Issued to Compounding Pharmacies Regarding Violations of Current Good Manufacturing Practices Between 2017 and 2022.
    Dmour I
    J Pharm Innov; 2022 Nov; ():1-15. PubMed ID: 36407089
    [TBL] [Abstract][Full Text] [Related]  

  • 14. American Society of Clinical Oncology policy statement: oversight of clinical research.
    American Society of Clinical Oncology
    J Clin Oncol; 2003 Jun; 21(12):2377-86. PubMed ID: 12721281
    [TBL] [Abstract][Full Text] [Related]  

  • 15. "We measure what we can measure": Struggles in defining and evaluating institutional review board quality.
    Lynch HF; Eriksen W; Clapp JT
    Soc Sci Med; 2022 Jan; 292():114614. PubMed ID: 34861569
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective Study.
    Bablani S; Janodia MD
    Ther Innov Regul Sci; 2020 Jul; 54(4):925-931. PubMed ID: 32557315
    [TBL] [Abstract][Full Text] [Related]  

  • 17. The interrelationship of sponsors, clinical investigators, and institutional review boards.
    Kirsch TJ
    Drug Inf J; 1987; 21(2):127-31. PubMed ID: 10282113
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study.
    Lurie P; Chahal HS; Sigelman DW; Stacy S; Sclar J; Ddamulira B
    BMJ; 2015 Jun; 350():h2758. PubMed ID: 26063327
    [TBL] [Abstract][Full Text] [Related]  

  • 19. The development and acceptance of a simple tool to aid IRB compliance.
    Vulcano DM
    Qual Manag Health Care; 2012; 21(3):203-8. PubMed ID: 22722526
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Research Misconduct in FDA-Regulated Clinical Trials: A Cross-sectional Analysis of Warning Letters and Disqualification Proceedings.
    Garmendia CA; Bhansali N; Madhivanan P
    Ther Innov Regul Sci; 2018 Sep; 52(5):592-605. PubMed ID: 29714564
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.