Schwieterman William D
Tekgenics, Inc., 3901 Point Road, Mobile, AL 36619, USA.
Drug Discov Today. 2006 Oct;11(19-20):945-51. doi: 10.1016/j.drudis.2006.08.011. Epub 2006 Sep 7.
The FDA has recently transferred jurisdiction for the regulation of certain biopharmaceuticals from the Center for Biologics, Evaluation and Research to the Center for Drugs, Evaluation and Research, where they will be reviewed in the same FDA divisions as are traditional pharmaceutical agents. With this transfer, sponsors of investigational biopharmaceuticals should expect changes in the regulatory requirements the FDA imposes on the clinical development plans, including an increase in the size and number of pivotal studies; more consistent requirements for conducting preclinical tests in two animal species; increased emphasis on organ structure and function as components of primary endpoints; more emphasis on characterizing dose-ranging and pharmacology; more intense scrutinizing of product advertising; and decreased direct communication with the review team.
美国食品药品监督管理局（FDA）最近已将某些生物制药的监管管辖权从生物制品评估和研究中心转移至药品评估和研究中心，在该中心，这些生物制药将与传统药物制剂一样在FDA的相同部门接受审评。随着这一转移，研究性生物制药的申办方应预计到FDA对临床开发计划所施加的监管要求会发生变化，包括关键研究的规模和数量增加；对在两种动物物种中进行临床前试验的要求更加一致；更加重视将器官结构和功能作为主要终点的组成部分；更加注重确定剂量范围和药理学特征；对产品广告进行更严格的审查；以及与审评团队的直接沟通减少。
