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GUIDANCE DOCUMENT

E15 Pharmacogenomics Definitions and Sample Coding April 2008

Final

E15 Pharmacogenomics Definitions and Sample Coding

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance contains definitions of key terms in the discipline of pharmacogenomics and
pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data
and sample coding categories. In the effort to develop harmonized approaches to drug regulation, it
is important to ensure that consistent definitions of terminology are being applied across all
constituents of the International Conference on Harmonisation (ICH). This guidance on definitions
is intended to facilitate the integration of the discipline of pharmacogenomics and
pharmacogenetics into global drug development and approval processes. As new scientific knowledge
in the discipline of pharmacogenomics and pharmacogenetics emerges, the current guidance will be
reviewed and expanded if appropriate.
 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.