We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Reporting of serious AEs to FDA often delayed by drug companies.
- Authors
Hower, Casey
- Abstract
The article presents a study led by Paul Ma of the University of Minnesota's Carlson School of Management as of late August 2015, which showed that almost 10% of adverse events (AE) are not reported by companies to the U.S. Food and Drug Administration (FDA) within the required 15-day period. In the study, data from the FDA's Adverse Event Reporting System in January 2004-June 2014 were analyzed. Also cited is the comment by "JAMA Internal Medicine" editor Rita F. Redberg on the issue.
- Subjects
PHARMACEUTICAL industry; UNITED States. Food &; Drug Administration; ADVERSE health care events
- Publication
Ocular Surgery News, 2015, Vol 33, Issue 16, p15
- ISSN
8750-3085
- Publication type
Article