The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: Report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group [PDF]
, 2018 Expedited pathways to antimicrobial agent approval by the U.S. Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices.
Burnham, Carey-Ann D +6 more
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Evidence of comparative efficacy should have a formal role in European drug approvals [PDF]
, 2011 Despite methodological concerns, comparative efficacy evidence should be required at the time of drug approval, says Corinna Sorenson and colleagues, to allow patients, clinicians, and other healthcare decision makers to determine whether a new drug is ...
Cylus, Jonathan +3 more
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Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored [PDF]
, 2005 Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret to ...
Boyce, Janene
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An analysis of common ethical justifications for compassionate use programs for experimental drugs [PDF]
, 2016 BACKGROUND: When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years.
Raus, Kasper
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Communication and Freedom: An Althusserian Reading of Media-Government Relations [PDF]
, 2000 This essay draws on the work of French philosopher Louis Althusser, particularly his contributions to the development of ideology, in an assessment of the relationship between communication ana freedom.
Brennen, Bonnie
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Urine Screening for Opiod and Illicit Drugs in the Total Joint Arthroplasty Population [PDF]
, 2020 Introduction. Recent studies have shown an increase in post-operative orthopaedic complications associated with pre-operative opioid use. It is, therefore, important to know if patients use opioids before scheduled surgery.
Bhargava, Tarun +6 more
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Abiraterone acetate in metastatic castration-resistant prostate cancer after chemotherapy. A retrospective “Real Life” analysis of activity and safety [PDF]
, 2015 Abiraterone acetate (AA) is a potent, selective androge (CYP17) biosynthesis inhibitor, which showed to improve overall survival (HR = 0.646) in mCRPC patients progressing after docetaxel.
A., Giuli +16 more
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Ethical Issues in the Drug Approval Process [PDF]
, 2013 The Food and Drug Administration’s (FDA) drug approval process carries great significance for both pharmaceutical companies and for patients. In recent decades, there has been a shift towards expedited approval so that drugs, especially those for ...
McInnis, Meghan
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Biovail v. Hoechst Aktiengesellschaf, Inc: An Analysis Under the Sherman Act and the Noerr-Pennington Doctrine [PDF]
, 2017 The Hatch-Waxman Act of 1984 regulates approval by the Food and Drug Administration (“FDA”) of generic counterparts to patented drugs. In a series of recent cases, large pharmaceutical companies have been accused of exploiting Hatch-Waxman in violation ...
Resek, John F., Ph.D.
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Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. [PDF]
, 2008 BackgroundPrevious studies of drug trials submitted to regulatory authorities have documented selective reporting of both entire trials and favorable results.
Bacchetti, Peter +2 more
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