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What schools need, he said, is something like NICE (the National Institute for Health and Clinical Excellence), the public body that assesses medicines and medical techniques for safety, clinical efficacy and cost effectiveness.
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"There is a significant body of scientific and clinical evidence supporting the safety and efficacy of ginkgo extract for both cognitive function and improved circulation, " said Mark Blumenthal, executive director of the American Botanical Council.
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The day before the opening today of the ASH conference in Atlanta, TG Therapeitics announced it has initiated a phase 1 and 2 clinical trials to evaluate the safety, tolerability and efficacy of its product, TG-1101, a novel third-generation anti-CD20 monoclonal antibody, in combination with Revilimid for patients with relapsed or refractory B-cell lymphoid malignancies who were previously treated with anti-CD20 antibody therapy.
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The 1960s were when the Food and Drug Administration, in the wake of the thalidomide scandal, started requiring proof of efficacy and long-term safety, and when medicine started relying on clinical trials that compared new treatments to old ones or to inert sugar pills.
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Still others work on company-funded clinical trials, the main way that medicines are studied for safety and efficacy.
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If the drug candidate is derived from an herbal medicine that is legally marketed and hasn't caused safety problems, it may be able to skip the early-stage safety trial and go right to midstage clinical trials, which measure efficacy and determine proper dosing.
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