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18 results
  • Evidence-based pharmacotherapy of treatment-resistant unipolar depression. [Review]
    Int J Psychiatry Clin Pract 2017; 21(1):13-23Dold M, Kasper S
  • Treatment resistance to the antidepressive pharmacotherapy represents one of the most important clinical challenges in the pharmacological management of unipolar depression. In this review, we aimed to summarise the evidence for various pharmacological treatment options in therapy-resistant unipolar depression derived from clinical trials, systematic reviews, meta-analyses and treatment guideline…
  • Do We Need Stronger Sanctions to Ensure Legal Compliance By Pharmaceutical Firms? [Journal Article]
    Food Drug Law J 2015; 70(3):435-52, iiRodwin MA
  • The increasing number of enforcement lawsuits against pharmaceutical firms and the large size of settlement payments suggest that misconduct is widespread and even risks slipping into the banalities of ordinary business practices. It also raises questions as to whether current sanctions are an effective means to ensure compliance. This article explores the causes of the frequent illegal conduct, …
  • Your business in court: 2009-2010. [Journal Article]
    Food Drug Law J 2011; 66(2):139-81, iReiss JB, Hall CR, Wartman GJ
  • During this period, FDA focused considerable effort on its transparency initiative, which is likely to continue into the coming year, as well as continuing to ramp up its enforcement activities, as we predicted last year. The scope of the agency's ability to pre-empt state laws in product liability litigation involving pharmaceutical products still is developing post-Levine, and we are likely to …
  • ORI findings of scientific misconduct in clinical trials and publicly funded research, 1992-2002. [Journal Article]
    Clin Trials 2004; 1(6):509-16Reynolds SM
  • CONCLUSIONS: In clinical trials, junior employees may bear the burden of sanction for scientific misconduct. The most frequently applied sanction was the requirement that a plan of supervision of the sanctioned employees accompany any future application for funding which would include them. This imposition of sanction on an individual employee does not address possible causes of misconduct which may be inherent in the overall pattern of leadership, training and supervision in the trial. Furthermore, the definition of misconduct, as interpreted by the Departmental Appeals Board, excludes carelessness and other poor research practices that may lead to dissemination of more incorrect data than misconduct.
  • Scientific misconduct and findings against graduate and medical students. [Journal Article]
    Sci Eng Ethics 2004; 10(3):483-91Parrish DM
  • Allegations of scientific misconduct against graduate students appear to have unique attributes in the detection, investigation, processes used and sanctions imposed vis-à-vis other populations against which misconduct is alleged and found. An examination of the cases closed by the Department of Health and Human Services' Office of Research Integrity and the National Science Foundation reveals th…
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