The impact of drug-related QT prolongation on FDA regulatory decisions.
Division of Cardiovascular and Renal Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Association, Silver Spring, MD, USA.
Eunjung
E
Park
James
J
Willard
Daoqin
D
Bi
Monica
M
Fiszman
Devi
D
Kozeli
John
J
Koerner
D017277:Drug Approval; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008133:Long QT Syndrome / Q000139:chemically induced*; D014481:United States; D014486:United States Food and Drug Administration
Drug approval; QT prolongation; Safety warning