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GUIDANCE DOCUMENT

Qualification of Biomarker — Galactomannan in studies of treatments of invasive November 2015

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2013-D-1630
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the Center for Drug Evaluation and Research, Biomarker Qualification Program (email: CDER-BiomarkerQualificationProgram@fda.hhs.gov).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-1630.

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