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Flexibility and innovation in FDA's novel regulatory approval strategies for hematologic drugs
Blood ( IF 20.3 ) Pub Date : 2017-09-14 , DOI: 10.1182/blood-2017-04-742726
Ann T. Farrell 1 , Kirsten B. Goldberg 1 , Richard Pazdur 1, 2
Affiliation  

The US Food and Drug Administration (FDA) negotiates the evidence necessary for drug approval with pharmaceutical sponsors. The resulting data package submitted in support of approval includes labeling that conveys the benefits and risks of a particular agent. Recent approvals in hematology

中文翻译:

FDA 新的血液药物监管批准策略的灵活性和创新性

美国食品和药物管理局 (FDA) 与药物赞助商协商药物批准所需的证据。为支持批准而提交的最终数据包包括传达特定代理的利益和风险的标签。血液学的最新批准
更新日期:2017-09-14
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