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最近 ,美国FDA内分泌和代谢药物顾问委员会的多数人同意 ,评价体重控制药物长期服用是否安全和有效的临床试验只需 12个月 ,而非过去的 2年。FDA计划更新 1996年对体重控制药物进行临床评估的指导原则 ,委员会对这类化合物进行Ⅲ期临床试验执行标准的大多数文件表示认可。所有
Most recently, the majority of the FDA’s Endocrinology and Metabolic Medicine Advisory Committee agreed that clinical trials evaluating the long-term use of weight-control drugs are safe and effective are only 12 months instead of the last two years. The FDA plans to update guidelines for clinical evaluation of weight-control drugs in 1996 and the committee endorsed most of the documents on the implementation of phase III clinical trials of such compounds. all