Pharmacogenomic data: FDA voluntary and required submission guidance.
Salerno
Ronald A
RA
Worldwide Regulatory Affairs, Wyeth Research, Collegeville, PA 19426, USA. salernr@wyeth.com
Lesko
Lawrence J
LJ
D000818:Animals; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods; D006801:Humans; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence* / Q000592:standards