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

JAMA Intern Med. 2015 Sep;175(9):1565-6. doi: 10.1001/jamainternmed.2015.3565.

Authors

Paul Ma¹, Iván Marinovic², Pinar Karaca-Mandic³

Affiliations

¹ Carlson School of Management, University of Minnesota, Minneapolis.
² Graduate School of Business, Stanford University, Palo Alto, California.
³ Division of Health Policy and Management, University of Minnesota School of Public Health, Minneapolis4National Bureau of Economic Research, Cambridge, Massachusetts.

PMID: 26214395
DOI: 10.1001/jamainternmed.2015.3565

No abstract available

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Adverse Drug Reaction Reporting Systems / statistics & numerical data*
Disclosure / statistics & numerical data*
Drug-Related Side Effects and Adverse Reactions*
Humans
Time Factors
United States
United States Food and Drug Administration

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