The FDA's sentinel initiative-A comprehensive approach to medical product surveillance

In May 2008, the Department of Health and Human Services announced the launch of the Sentinel Initiative by the US Food and Drug Administration (FDA) to create the Sentinel System, a national electronic system for medical product safety surveillance. This system complements existing FDA surveillance...

Full description

Saved in:
Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2016-03, Vol.99 (3), p.265-268
Main Authors: Ball, R, Robb, M, Anderson, SA, Dal Pan, G
Format: Article
Language:English
Subjects:
Adverse Drug Reaction Reporting Systems
Equipment and Supplies - adverse effects
Equipment and Supplies - standards
Humans
Pharmacovigilance
Product Surveillance, Postmarketing
United States
United States Food and Drug Administration - legislation & jurisprudence
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:In May 2008, the Department of Health and Human Services announced the launch of the Sentinel Initiative by the US Food and Drug Administration (FDA) to create the Sentinel System, a national electronic system for medical product safety surveillance. This system complements existing FDA surveillance capabilities that track adverse events reported after the use of FDA regulated products by allowing the FDA to proactively assess the safety of these products.
ISSN:0009-9236
1532-6535
DOI:10.1002/cpt.320