Related Links


Center for Biomarker Research:

Bioinformatics Tools:

The Biomarker Consortium, FNIH:


Drug Development:

Tufts Center for the Study of Drug Development:



Hap Map Project:

Seattle SNPs:

UCSC Genome Browser:

Online Mendelian Inheritance in Man (OMIM):


Search Publications:


PubMed Central:


Journals, etc.:

Nature Reviews Drug Discovery:


New England Journal of Medicine:

Journal of Immunology:


Regulatory Agencies and Guidance

Exploratory IND Guidance (FDA):
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FDA Employee Directory:


FDA Guidance

What’s new at CEDR:


EMEA and Industry

FDA E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
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FDA (Biomarker) Qualification Process for Drug Development Tools
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FDA Guidance for Industry Pharmacogenomic Data Submissions
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FDA Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff: note that this is for diagnostic tests used in conjunction with drugs and during drug development as companion diagnostics
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FDA: Drug Development Tools: The Drug Development Tools (DDTs) Qualification Program was created by CDER as part of the FDA's Critical Path Initiative (CPI) to provide a framework for development and regulatory acceptance of scientific tools for use in drug development programs. DDT qualification programs currently exist for biomarkers1, clinical outcome assessments2 (COAs), and animal models3 for use under the Animal Rule.


new book:
Translational Medicine and Drug Discovery
Published by the Cambridge University Press
Reviewed in Drug Information Journal, PDF:
"This is an important book in a relatively new and growing field. Anyone engaged in advanced research designed to bring new drugs and biologics to market will find it valuable."