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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >FDA TO MAKE IT EASIER FOR DRUG MAKERS TO GIVE PEDIATRIC-DOSE DATA TO DOCTORS
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FDA TO MAKE IT EASIER FOR DRUG MAKERS TO GIVE PEDIATRIC-DOSE DATA TO DOCTORS

机译:FDA使药物制造商更轻松地将儿科剂量数据提供给医生

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The Food and Drug Administration plans to make it easier for pharmaceutical manufacturers to provide doctors with information on the proper doses of prescription drugs for children.FDA Commissioner David Kessler is expected to announce plans today to allow manufacturers in some circumstances to provide pediatric-use information on drug labels, even if they haven't held full-blown clinical trials involving children. The information would be based on extrapolations from adult studies, plus other data about the effects on children.
机译:美国食品药品监督管理局(FDA)计划简化药品生产商向医生提供有关儿童处方药剂量的信息。FDA专员戴维·凯斯勒(David Kessler)今天将宣布计划,允许生产商在某些情况下提供儿科用药信息。药物标签上的标签,即使他们尚未进行涉及儿童的全面临床试验。该信息将基于成人研究的推论,以及有关对儿童影响的其他数据。

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