The impact of drug-related QT prolongation on FDA regulatory decisions

Int J Cardiol. 2013 Oct 12;168(5):4975-6. doi: 10.1016/j.ijcard.2013.07.136. Epub 2013 Aug 3.

Authors

Eunjung Park¹, James Willard, Daoqin Bi, Monica Fiszman, Devi Kozeli, John Koerner

Affiliation

¹ Division of Cardiovascular and Renal Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Association, Silver Spring, MD, USA.

PMID: 23920061
DOI: 10.1016/j.ijcard.2013.07.136

No abstract available

Keywords: Drug approval; QT prolongation; Safety warning.

Publication types

Letter
Research Support, U.S. Gov't, P.H.S.

MeSH terms

Drug Approval*
Drug Interactions
Drug-Related Side Effects and Adverse Reactions*
Humans
Long QT Syndrome / chemically induced*
United States
United States Food and Drug Administration