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Part 1: Document Description
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Citation |
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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” |
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Identification Number: |
doi:10.7910/DVN/27191 |
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Distributor: |
Harvard Dataverse |
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Date of Distribution: |
2014-08-26 |
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Version: |
1 |
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Bibliographic Citation: |
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”", https://doi.org/10.7910/DVN/27191, Harvard Dataverse, V1 |
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Citation |
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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” |
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Identification Number: |
doi:10.7910/DVN/27191 |
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Authoring Entity: |
Schick, Andreas (The Food and Drug Administration) |
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Lanthier, Michael (The Food and Drug Administration) |
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Nardinelli, Clark (The Food and Drug Administration) |
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Producer: |
Andreas Schick |
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Distributor: |
Harvard Dataverse |
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Access Authority: |
Andreas Schick |
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Depositor: |
Andreas Schick |
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Date of Deposit: |
2014-08-26 |
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Date of Distribution: |
2012 |
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Holdings Information: |
https://doi.org/10.7910/DVN/27191 |
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Study Scope |
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Keywords: |
PDUFA Review Times Boxed Warnings Safety-Based Withdrawals Prescription Drug User Fee Act |
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Abstract: |
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. |
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Time Period: |
1992-2006 |
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Date of Collection: |
2011-2012 |
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Methodology and Processing |
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Sources Statement |
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Data Access |
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Notes: |
<a href="http://creativecommons.org/publicdomain/zero/1.0">CC0 1.0</a> |
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Other Study Description Materials |
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Label: |
How to recreate results.docx |
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Text: |
This document discusses how independent researchers can recreate our results. |
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Notes: |
application/vnd.openxmlformats-officedocument.wordprocessingml.document |
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Label: |
Original Carpenter Dataset.xlsx |
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Text: |
This is the original data set that Carpenter et al. used to conduct their analysis. We use this data set to recreate their results. |
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Notes: |
application/vnd.openxmlformats-officedocument.spreadsheetml.sheet |
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Label: |
Original with omitted drugs.xls |
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Text: |
This data set includes, into the original with variable changes data set, the 17 PDUFA drugs that Carpenter et al. excluded from their study and removes 2 drugs that they mistakenly included. |
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Notes: |
application/vnd.ms-excel |
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Label: |
Original with variable changes.xls |
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Text: |
This data set includes, into the original carpenter data set, the 24 corrections associated with their review deadline, boxed warning, and safety-based withdrawal measures. |
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Notes: |
application/vnd.ms-excel |