Articles
December 01, 2009
Personalized Medicines: Implications for Pharma
The President's Council of Advisors on Science and Technology defines personalized medicine as "tailoring medical treatment to the individual characteristics of each patient by classifying individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment." To this end, FDA is now developing guidelines that address the co-development of a drug and the companion diagnostic test (or diagnostic test and companion therapeutic) that will allow these subpopulations to be identified and treated accordingly.
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