I propose to raise funds for postapproval studies of long-term drug safety by augmenting the existing "user-fee" system. Fees would be raised by an amount deemed optimal for revenue collection, and the U.S. Food and Drug Administration (FDA) would direct the incremental funds to a combination of randomized controlled trials, epidemiological studies, and postmarketing surveillance. User-fee augmentation is an achievable, incremental reform that would subsidize information that is now undersupplied in the U.S. health care system; spread the burden of funding postmarketing safety studies among pharmaceutical sponsors; and help restore public, scientific, and professional confidence in the FDA and its user-fee system.

译文

:我建议通过增加现有的“用户费用”系统来为长期药物安全性的批准后研究筹集资金。费用将提高至最适合收税的数额,美国食品药品监督管理局(FDA)将把增加的资金用于随机对照试验,流行病学研究和上市后监督的组合。增加用户费用是一项可以实现的渐进式改革,将对目前美国医疗保健系统中供应不足的信息提供补贴;在药品赞助商之间分散进行售后安全性研究的资金负担;并帮助恢复公众,科学和专业人士对FDA及其用户费用系统的信心。

+1
+2
100研值 100研值 ¥99课程
检索文献一次
下载文献一次

去下载>

成功解锁2个技能,为你点赞

《SCI写作十大必备语法》
解决你的SCI语法难题!

技能熟练度+1

视频课《玩转文献检索》
让你成为检索达人!

恭喜完成新手挑战

手机微信扫一扫,添加好友领取

免费领《Endnote文献管理工具+教程》

微信扫码, 免费领取

手机登录

获取验证码
登录