7月10日,FDA公布了202封完整的回复函(CRL),针对2020年至2024年期间提交给FDA药品或生物制品的审批申请。所有CRL均详细说明了药品未通过的原因及建议。对此,FDA局长Marty Makary表示,过去药企如同在审批迷宫中猜谜,资本与创新都需要可预测性。“今天我们推动的透明革命,终将让有效疗法更快抵达患者。”根据FDA研究人员2015年的一项分析,申办方在公开宣布其申请未获批准时...
Source Link7月10日,FDA公布了202封完整的回复函(CRL),针对2020年至2024年期间提交给FDA药品或生物制品的审批申请。所有CRL均详细说明了药品未通过的原因及建议。对此,FDA局长Marty Makary表示,过去药企如同在审批迷宫中猜谜,资本与创新都需要可预测性。“今天我们推动的透明革命,终将让有效疗法更快抵达患者。”根据FDA研究人员2015年的一项分析,申办方在公开宣布其申请未获批准时...
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