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Encysive’s blood clot prevention drug Argatroban, approved to prevent blood clots in heart attack victims, may also help open blocked arteries in stroke patients, according to a study published in the Aug. 14 issue of Archives of Neurology.
The House passed a sweeping health information technology (HIT) bill July 27 that includes a provision designed to boost the use of electronic clinical trial data, but Democrats are attacking the bill, arguing that it would not improve technology adoption but would endanger the privacy of patient medical records.
The House July 27 passed a sweeping health information technology (HIT) bill that includes a provision designed to boost the use of electronic clinical trial data, but the measure came under swift attack by Democrats who charged that it would not improve technology adoption but would endanger the privacy of patient medical records.
Encouraging data from clinical trials of GlaxoSmithKline’s (GSK’s) pandemic bird flu vaccine have led the company to announce that it will likely file for regulatory approval to market the product in the next few months.
Several new products and partnerships in the field of electronic data capture (EDC) were unveiled at the Drug Industry Association’s (DIA) annual conference in Philadelphia in June.
The FDA faces an initial obstacle in its new effort to promote adaptive clinical trials: a lack of industry consensus as to what these trials entail, industry officials say.
The FDA has partially lifted the clinical hold on Corautus Genetics’ GENASIS Phase IIb clinical trial of its VEGF-2 therapy for cardiovascular (severe angina) disease and peripheral vascular disease, the company said July 13.
While the FDA is preparing at least five new guidances to promote adaptive clinical trials, experts at a recent industry conference disagreed significantly on what exactly an adaptive clinical trial is.
Recent guidance issued by Health Canada spells out requirements for sponsors, qualified investigators, and ethical review boards regarding the preparation, maintenance and availability of clinical trial records.