By streamlining the qualification process for biomarkers, coordinated protocols recently implemented at the different regulatory agencies can facilitate progress and provide impetus to novel biomarker discovery and validation.
This is a preview of subscription content, access via your institution
Access options
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on SpringerLink
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
European Agency for the Evaluation of Medical Products. Public Statement: EU–US FDA Bilateral Agreement (EMEA, London, UK, 2003; accessed 8 September 2009). http://www.emea.europa.eu/pdfs/general/direct/pr/2447803en.pdf
The Food and Drug Administration. Guidance for Industry: Pharmacogenomic Data Submissions (FDA, Rockville, Maryland, USA, March 2005; accessed 8 September 2009). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079849.pdf
European Agency for the Evaluation of Medical Products. Medicines and Emerging Science (EMEA, London, UK, accessed 8 September 2009) http://www.emea.europa.eu/htms/human/mes/emergingtechnologies.htm
The Food and Drug Administration. Fed. Reg. 69, 48876–48877 (2004). http://www.fda.gov/OHRMS/DOCKETS/98fr/04-18360.htm
The European Medicines Agency. EMEA/CHMP/PGxWP/20227/04 Guideline on Pharmacognetics Briefing Meetings (EMEA, London, UK, 2004; accessed 8 September 2009). http://www.ema.europa.eu/pdfs/human/pharmacogenetics/2022704en.pdf
Uyama, Y. Nippon Yakurigaku Zasshi 126, 432–435 (2005).
The Food and Drug Administration. Critical Path Initiative (FDA, Rockville, Maryland, USA, (2004) http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/default.htm
The European Medicines Agency. The European Medicines Agency Road Map to 2015: Preparing the Ground for the Future (EMEA, London, UK, 2010; 8 September 2009). http://www.emea.europa.eu/htms/general/direct/roadmap/roadmapintro.htm
The European Medicines Agency. Innovative Drug Development Approaches (EMEA/127318/2007)—Final Report of the EMEA/CHMP Think-Tank on Innovative Drug Development (EMEA, London, UK, 2007; accessed 8 September 2009). http://www.ema.europa.eu/pdfs/human/itf/12731807en.pdf
Goodsaid, F.M., Frueh, F.W. & Mattes, W. Toxicology. 245, 219–223 (2008).
Hunter, A.J. Drug Discov. Today. 13, 371–373 (2008).
The European Medicines Agency. Final Report on the Pilot Joint EMEA/FDA VXDS Experience on Qualification of Nephrotoxicity Biomarkers (EMEA, London, UK, May 2008; accessed 8 September 2009). http://www.ema.europa.eu/pdfs/human/biomarkers/25088508en.pdf
Altar, C.A. et al. Clin. Pharmacol. Ther. 83, 368–371 (2008).
Lathia, C.D. et al. Clin. Pharmacol. Ther. 86, 32–43 (2009).
The Food and Drug Administration. E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions (FDA, Rockville, Maryland, USA; accessed 8 September 2009). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174433.pdf
The Food and Drug Administration. Fed. Reg. 69, 42060–42061 (2004; accessed 8 September 2009). http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15935.htm
The Food and Drug Administration. Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels (FDA, Rockville, Maryland, USA; accessed 8 September 2009). http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083378.htm.
The European Medicines Agency. Guidance Document on the Qualification of Novel Methodologies for Drug Development (EMEA, London, UK, January 2009; accessed 8 September 2009). http://www.ema.europa.eu/pdfs/human/biomarkers/7289408en.pdf
Author information
Authors and Affiliations
Corresponding authors
Ethics declarations
Competing interests
The authors declare no competing financial interests.
Rights and permissions
About this article
Cite this article
Goodsaid, F., Papaluca, M. Evolution of biomarker qualification at the health authorities. Nat Biotechnol 28, 441–443 (2010). https://doi.org/10.1038/nbt0510-441
Issue Date:
DOI: https://doi.org/10.1038/nbt0510-441
This article is cited by
-
Early markers of obesity-related renal injury in childhood
Pediatric Nephrology (2015)
-
Development of Blood Biomarkers for Drug-Induced Liver Injury: An Evaluation of Their Potential for Risk Assessment and Diagnostics
Molecular Diagnosis & Therapy (2013)
-
The Analytical Aspects and Regulatory Challenges of Biomarker Discovery: Examples from the Field of Neurodegeneration
Current Translational Geriatrics and Experimental Gerontology Reports (2012)
-
Predictive biomarkers: a paradigm shift towards personalized cancer medicine
Nature Reviews Clinical Oncology (2011)
-
Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium
Nature Biotechnology (2010)