Mini-Sentinel is a pilot project sponsored by the U.S. FDA to inform and facilitate development of a fully operational active surveillance system, the Sentinel System, for monitoring the safety of FDA-regulated medical products. Mini-Sentinel is one piece of the Sentinel Initiative, a multifaceted effort by the FDA to develop a national electronic system that will complement existing methods of safety surveillance. A related White Paper was developed as part of this initiative and can be found at: http://mini-sentinel.org/methods/methods_development/details.aspx?ID=1038?
A critical review of methods to evaluate the impact of FDA regulatory actions†
Article first published online: 12 JUL 2013
Copyright © 2013 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 22, Issue 9, pages 986–994, September 2013
How to Cite
Briesacher, B. A., Soumerai, S. B., Zhang, F., Toh, S., Andrade, S. E., Wagner, J. L., Shoaibi, A. and Gurwitz, J. H. (2013), A critical review of methods to evaluate the impact of FDA regulatory actions. Pharmacoepidem. Drug Safe., 22: 986–994. doi: 10.1002/pds.3480
- Issue published online: 20 AUG 2013
- Article first published online: 12 JUL 2013
- Manuscript Accepted: 13 JUN 2013
- Manuscript Revised: 5 JUN 2013
- Manuscript Received: 25 JAN 2013
- FDA. Grant Number: HHSF223200910006I
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