Time Enough for Safety: Comment on “The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety”

Name: Time Enough for Safety: Comment on “The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety”
Creator: The Food and Drug Administration
Published: 2012-01-01T00:00:00+08:00

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https://dataverse.harvard.edu/citation?persistentId=doi:10.7910/DVN/27191 数据链接链接失效反馈

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资源简介：

Carpenter, Chattopadhyay, Moffitt, and Nall (2012) present results that suggest that time constraints on new-drug reviews are positively associated with post-market safety outcomes. However, their analysis omits obvious confounding variables, and their data set contains several clear errors. In regressions using a clean data set and plausible confounding variables, we find that the relationship between time constraints on new-drug reviews and post-market safety events is neither robust nor statistically significant.

提供机构：

The Food and Drug Administration

创建时间：

2012-01-01