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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”      
dateReleased:
08-26-2014
downloadURL: http://dx.doi.org/10.7910/DVN/27191
ID:
doi:10.7910/DVN/27191
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.
description:
Schick, Andreas; Lanthier, Michael; Nardinelli, Clark, 2014, "Time Enough for Safety: Comment on “The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety”", http://dx.doi.org/10.7910/DVN/27191, Harvard Dataverse, V1
name:
Schick, Andreas
Lanthier, Michael
Nardinelli, Clark
homePage: http://www.harvard.edu/
name:
Harvard University
ID:
SCR:011273
abbreviation:
DataVerse
homePage: http://thedata.org/
name:
Dataverse Network Project
ID:
SCR:001997