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The U.S. Food and Drug Administration said on Monday it is launching a series of measures to speed up drug research, from early-stage investigational studies to late-stage trials, under an initiative called Operation TrialBlazer.
The FDA said it is planning a new pilot program that would pair drug sponsors with qualified research institutions such as academic medical centers and contract research organizations to shorten the time from drug identification to first-in-human studies.
美国食品和药物管理局(FDA)周一表示,将在一项名为Operation TrialBlazer的行动中推出一系列措施,从早期研究性研究到晚期临床试验,加快药物研发速度。
FDA表示,正规划一个新的试点项目,将药物赞助商与合格的研究机构(如学术医疗中心和合同研究组织)配对,以缩短从药物识别到首次人体研究的时间。
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