Biomarkers:
Center for Biomarker Research:
http://www.futuremedicine.com/doi/abs/10.2217/pme.12.52
Bioinformatics Tools: http://snpper.chip.org
The Biomarker Consortium, FNIH: http://www.biomarkersconsortium.org
Drug Development:
Tufts Center for the Study of Drug Development: http://csdd.tufts.edu
Genomics:
Hap Map Project:
http://hapmap.ncbi.nlm.nih.gov/index.html.en
Seattle SNPs: http://pga.gs.washington.edu
UCSC Genome Browser: http://genome.ucsc.edu
Online Mendelian Inheritance in Man (OMIM):
http://omim.org
Search Publications:
PubMed: http://www.ncbi.nlm.nih.gov/sites/entrez
PubMed Central: http://www.pubmedcentral.nih.gov
Journals, etc.:
Nature Reviews Drug Discovery: http://www.nature.com/nrd
Science: http://www.sciencemag.org
New England Journal of Medicine: http://content.nejm.org
Journal of Immunology: http://www.jimmunol.org/contents-by-date.0.shtml
Regulatory Agencies and Guidance
Exploratory IND Guidance (FDA):
download PDF
FDA Employee Directory: http://directory.psc.gov/employee.htm
FDA CEDR: http://www.fda.gov/cder/
FDA Guidance
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm
What’s new at CEDR: http://www.fda.gov/cder/whatsnew.htm
EMEA: http://www.emea.europa.eu
EMEA and Industry
http://www.ema.europa.eu/ema/index.jsp?curl=pages/audience/alp_audiencetype_000004.jsp&mid=
FDA E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
download PDF
FDA (Biomarker) Qualification Process for Drug Development Tools
download PDF
FDA Guidance for Industry Pharmacogenomic Data Submissions
download PDF
FDA Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff: note that this is for diagnostic tests used in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
download PDF
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.
http://www.fda.gov/drugs/developmentapprovalprocess/drugdevelopmenttoolsqualificationprogram/default.htm
