title: Pharmacogenomic data: FDA voluntary and required submission guidance.
authors.affiliation: Worldwide Regulatory Affairs, Wyeth Research, Collegeville, PA 19426, USA. salernr@wyeth.com
authors.forename: Ronald A
authors.initials: RA
authors.lastname: Salerno
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Lesko
mesh_terms: 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