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GUIDANCE DOCUMENT

E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions August 2011

Final

E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions

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

The guidance describes recommendations regarding context, structure and format of regulatory
submissions for qualification of genomic biomarkers (as defined in ICH E15 3). Qualification is a
conclusion that, within the stated context of use, the results of assessment with a biomarker can
be relied upon to adequately reflect a biological process, response, or event, and support use of
the biomarker during drug or biotechnology product development, ranging from discovery through
postapproval. A biomarker qualification application might be submitted to regulatory authorities if
the biomarker directly or indirectly helps in regulatory decision-making.
 


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.