FDA Issues Guidance Defining Key Terms in Pharmacogenomics

April 9, 2008
Chitra Sethi

Chitra Sethi, Managing Editor, BioPharm International

In its effort to ensure that consistent definitions of terminology are being applied by all constituents of the ICH, the FDA has released a new guidance, E15, containing definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics.

In its effort to ensure that consistent definitions of terminology are being applied by all constituents of the International Conference on Harmonization (ICH), the FDA has released a new guidance, E15, containing definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics. The key terms include genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories.

This guidance has been endorsed by the ICH Steering Committee at Step 4 of the ICH process as of November 2007. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States.

According to the FDA, this guidance on definitions is intended to facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes.

Guidance document (PDF)