Record Details

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

Harvard Dataverse (Africa Rice Center, Bioversity International, CCAFS, CIAT, IFPRI, IRRI and WorldFish)

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Title Time Enough for Safety: Comment on “The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety”
 
Identifier https://doi.org/10.7910/DVN/27191
 
Creator Schick, Andreas
Lanthier, Michael
Nardinelli, Clark
 
Publisher Harvard Dataverse
 
Description 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.
 
Subject PDUFA Review Times Boxed Warnings Safety-Based Withdrawals Prescription Drug User Fee Act
 
Contributor Andreas Schick