Guidance for industry
Subtitle: pharmacogenomic data submissions, companion evidence
Contributors: National Center for Toxicological Research; Center for Biologics Evaluation and Research (U.S.); Center for Devices and Radiological Health (U.S.)
Publisher: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; National Center for Toxicological Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Research
Published: 2007
Place of publication: Rockville, MD
Language: eng
Format: [electronic resource] :
Number of pages: 25
Subjects: Pharmacogenomics; Government policy
Other titles: Pharmacogenomic data submissions, companion evidence
Notes: Title from PDF title page (viewed on June 2, 2009).

"Draft guidance."

"Procedural."

"August 2007."

Mode of access: Internet at the FDA web site. Address as of 6/2/09: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079855.pdf ; current access is available via PURL.