Pharmacogenomic data submissions to the FDA: non-clinical case studies.
Leighton
John K
JK
Division of Oncology Drug Products, CDER, FDA, 5600 Fishers Lane, Rockville, MD 20850, USA. leightonj@cder.fda.gov
DeGeorge
Joseph
J
Jacobson-Kram
David
D
MacGregor
James
J
Mendrick
Donna
D
Worobec
Alexandra
A
D016022:Case-Control Studies; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D006801:Humans; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence