加速药物研发——FDA 的新“突破性疗法”认定。
Expediting drug development--the FDA's new "breakthrough therapy" designation.
机构信息
From the Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.
出版信息
N Engl J Med. 2013 Nov 14;369(20):1877-80. doi: 10.1056/NEJMp1311439.
PMID:24224621
Abstract
The FDA's new "breakthrough therapy" designation for investigational drugs adds to the agency's portfolio of expedited programs for serious conditions. The designation requires preliminary clinical evidence demonstrating substantial improvement over existing therapies.
摘要
美国食品和药物管理局（FDA）对研究性药物的新“突破性疗法”指定增加了该机构对严重疾病的加速项目组合。该指定要求有初步的临床证据表明与现有疗法相比有实质性的改善。
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