CDER requests that a current list of approved chemistry, manufacturing and control information be provided yearly in the Annual Report to better document the changes occurring in applications. CDER要求已批准的化学,制造和控制信息的最新列表在年度报告中逐年提供。最好将申请文件中发生的变更文件化。
Recent regulatory experiences will then be described with analysis of investigational botanical drug submissions to the therapeutic divisions in FDA sCenter for Drug Evaluation and Research ( CDER). 下面将对递交FDA药物评价与研究中心(CDER)的植物新药研究进行评估,并说明最新的调控方案。