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2003年2月,FDA药物评价与研究中心(CDER)新药办公室主任Jenkins宣布FDA 成立了植物药审查小组(Botanical Review Team,BRT),专门审查植物药新产品的上市与临床试验的申请。Jenkins在备忘录中称,BRT在行政上隶属于第5药物评价办公室,BRT打算将该办公室的研究与管理职能整合起来,以一种资源履行审查新药临床研究申请(IND)和新药上市申请(NDA)的职责。对饮食补充剂的结构-功能要求是否还需
In February 2003, Jenkins, director of the Office of New Drugs at the FDA Center for Drug Evaluation and Research (CDER), announced that the FDA has established the Botanical Review Team (BRT) to examine applications for the listing of new botanical drug products and clinical trials. Jenkins said in a memo that BRT is administratively affiliated with the 5th Drug Evaluation Office and that BRT intends to integrate the research and management functions of the office with a resource to perform reviews of new drug clinical research applications (INDs) and new drug listing applications (NDAs) ) Responsibility. The structure of dietary supplements - functional requirements are still needed