The US Food and Drug Administration-European Medicines Agency Collaboration in Pharmacovigilance: Common Objectives and Common Challenges

Gerald J. Dal Pan, Peter R. Arlett

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

Abstract

On 19 February 2014, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) announced the formation of a cluster on pharmacovigilance topics. The cluster is designed to complement, and not replace, other international activities in this field. It builds upon years of interactions between the two agencies. The creation of the cluster formalizes this longstanding and productive relationship and facilitates more systematic exchange of information and expertise.

Original languageEnglish (US)
Pages (from-to)13-15
Number of pages3
JournalDrug Safety
Volume38
Issue number1
DOIs
StatePublished - 2015
Externally publishedYes

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology
  • Toxicology
  • General Medicine

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