Regulatory Authority Guidance Documents

AgencyDateTitle
FDAAug 2011Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions
FDAOct 2010Qualification Process for Drug Development Tools
FDAApr 2008Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
FDAMar 2005Attachment to Guidance on Pharmacogenomic Data Submissions
FDAMar 2005Pharmacogenomic DataSubmissions
EMAJun 2009Genomic Biomarkers Related to Drug Response:Context, Structure and Format of Qualification Submissions
EMANov 2007Definitions for genomic biomarkers,pharmacogenomics, pharmacogenetics,genomic data and sample coding categories