Regulatory Authority Guidance Documents

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Agency	Date	Title
FDA	Aug 2011	Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions
FDA	Oct 2010	Qualification Process for Drug Development Tools
FDA	Apr 2008	Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
FDA	Mar 2005	Attachment to Guidance on Pharmacogenomic Data Submissions
FDA	Mar 2005	Pharmacogenomic DataSubmissions
EMA	Jun 2009	Genomic Biomarkers Related to Drug Response:Context, Structure and Format of Qualification Submissions
EMA	Nov 2007	Definitions for genomic biomarkers,pharmacogenomics, pharmacogenetics,genomic data and sample coding categories