In its draft, "Prescription Drug User Fee Act (PDUFA) iv Drug Safety Five-Year Plan," the agency says it will focus on hiring the staff through fiscal year 2009.
该计划草案为“处方药消费者付费法案(PDUFA)IV药品安全五年计划”,据相关机构介绍,该方案将会从2009年的年度财政中获取经费用于雇佣相关人员。
The FDA has accepted the Company's NDA for filing and has set a Prescription Drug User Fee act (PDUFA) target action date for the Company's NDA of January 23, 2008.
食品与药品管理局已经接受该公司的新药申请并将文件归档,而且还组织了处方药物使用权行动,活动目标是将公司新药注册日期定在2008年一月二十三日。
Thirty-four of 35 were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that FDA approved in less than six months.
34/35个药物是与药业工业在PDUFA下同意目标审评时间时或前被批准的,包括3个癌症药物FDA在短于6个月内批准。
Thirty-four of 35 were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that FDA approved in less than six months.
34/35个药物是与药业工业在PDUFA下同意目标审评时间时或前被批准的,包括3个癌症药物FDA在短于6个月内批准。
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