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Drug Manufacturers’ Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food and Drug Administration

Drug Manufacturers’ Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food... This study investigates patient and event characteristics associated with manufacturers’ delayed submission of expedited adverse event reports to the US Food and Drug Administration. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Drug Manufacturers’ Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food and Drug Administration

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Publisher
American Medical Association
Copyright
Copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2015.3565
pmid
26214395
Publisher site
See Article on Publisher Site

Abstract

This study investigates patient and event characteristics associated with manufacturers’ delayed submission of expedited adverse event reports to the US Food and Drug Administration.

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Sep 1, 2015

References

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