The FDAs sentinel initiative A comprehensive approach to medical product surveillance

R. Ball, M. Robb, S. A. Anderson, G. Dal Pan

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)265-268
Number of pages4
JournalClinical Pharmacology and Therapeutics
Volume99
Issue number3
DOIs
StatePublished - Mar 1 2016
Externally publishedYes

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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