FDAnews Drug Daily Bulletin

Pharmacogenomics Guidance Harmonizes Definitions

April 15, 2008

The FDA took the final step to harmonize pharmacogenomic definitions and sample coding guidance with that of Japan and the European Union by issuing its own guidance for comment.

The guideline — “E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories” — provides definitions and additional information related to aspects covered by the definitions and notes that certain principles discussed in the document may be applicable to related disciplines such as proteomics and metabalomics.

The guideline defines genomic biomarker as a measurable DNA or RNA characteristic that is an indicator of normal biologic or pathogenic processes or a response to therapeutic or other interventions. It defines pharmacogenomics as the study of variations of DNA and RNA characteristics as related to drug response. Pharmacogenetics is defined as the study of variations in DNA sequence as related to drug response.

The guideline also offers harmonized definitions for the four general coding categories of biological samples used to generate data in pharmacogenomic and pharmacogenetic studies.

The guidance is available at www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0199-gdl.pdf.