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Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification - PharmaFacts
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Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification

Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification

Guidance for Industry

U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

May 2016 Procedural

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Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification

Guidance for Industry

Additional copies are available from:

Office of Communications, Division of Drug Information Center for Drug Evaluation and Research

Food and Drug Administration th 10001 New Hampshire Ave., Hillandale Bldg., 4

Floor

Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

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U.S. Department of Health and Human Services Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

May 2016 Procedural

CLICK HERE FOR FULL GUIDANCE