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New Drug）启动人体临床试验，之後监管部门批准新药申请（英语：New Drug Application），這些流程都通過後，药物才能推向市场 。 Taylor, David. The Pharmaceutical Industry and the Future of Drug Development
March 2004 [24 June 2012]. （原始内容存档于2016-03-03）. Vertex Completes New Drug Application for Telaprevir for Hepatitis C (新闻稿). Vertex Pharmaceuticals. 23
而在支持學名药研发方面，學名药厂商在向FDA提出简化新药申请（英语：Abbreviated New Drug Application）（ANDA）时，无需再进行药物安全性、有效性等研究，而仅需提供生物有效性（英语：Bioequivalence）的试验结果。另外，
D. H., Goodie, J. L., Doyle, A., O'Quinn, S. R. Takeda Submits New Drug Application for Azilsartan Medoxomil in the U.S.. severehypertension.net. 2010-04-28
（原始内容存档于2020-12-09）. U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed