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New Drug Application (NDA) | FDA The following resources have been gathered to provide you with the legal requirements of a new drug application, assistance from CDER to help you meet those requirements, and internal NDA review
药物审批IND NDA BLA流程 - 知乎 当申请者有足够数据支撑药品安全性和有效性,符合 FDA 上市要求的,申请者可向 FDA 递交 NDA ,所有新药在美上市都必须经过新药审评过程,递交材料必须包含化学、药理、生物药剂和统计学等的技术性材料供审。