Experience with voluntary and required genomic data submissions to the FDA: summary report from track 1 of the third FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop

Pharmacogenomics J. 2006 Sep-Oct;6(5):296-300. doi: 10.1038/sj.tpj.6500380. Epub 2006 Mar 28.
No abstract available

Publication types

  • Congress

MeSH terms

  • Clinical Trials as Topic / legislation & jurisprudence
  • Clinical Trials as Topic / methods
  • Drug Approval*
  • Drug Industry / legislation & jurisprudence
  • Drug Industry / methods
  • Genomics*
  • Guidelines as Topic
  • Humans
  • Mandatory Reporting*
  • Pharmacogenetics / legislation & jurisprudence
  • Policy Making
  • Research Design / legislation & jurisprudence*
  • United States
  • United States Food and Drug Administration*
  • Volition*