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U.S. Department of Health and Human Services

Drugs

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Additional Resources

Presentations

 

Select Publications

1. Throckmorton DC. “How a US Regulator Can Encourage New Science”. Clin. Pharm. and Ther. 86 (5):471-472 (2009)

2. Goodsaid F. and Papaluca, M. “Evolution of biomarker qualification at the health authorities”. Nature Biotechnol. 28 (5):441- 443 (2010)

3. Dieterle, F. et al., “Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nature Biotechnol. 28 (5):455- 462 (2010)

4. Woodcock J. et al., “Qualifying biomarkers for use in drug development: a US Food and Drug Administration overview”. Expert Opin. Med. Diagn. 5(5):369-374 (2011)

5. Hausner EA. Et al., “Qualification of cardiac troponins for nonclinical use: A regulatory perspective”. Regul Toxicol Pharmacol. 2013 Jul 20. pii: S0273-2300(13)00108-6. doi: PMID:23876748

6. The Path from Biomarker Discovery to Regulatory Qualification, 1st Edition. (2013). Edited by Goodsaid and Mattes, Academic press, BN: 9780123914965

 

Websites

European Medical Agency (EMA): Qualification of novel methodologies for medicine development