Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies

Guidance for Industry
Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies



DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-301), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document, contact (CDER) Lawrence Lesko at 301-796-1565 or Shiew-Mei Huang at 301-796-1541, or (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 301-827-1800, or Changting Haudenschild at 301-827-3947, or (CDRH) Frances Kalush at 301-796-5408.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
February 2011
Clinical Pharmacology


download the draft document from FDA / pdf / 27 pages:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM243702.pdf