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Regulatory Focus™ > News Articles > Personalized Medicine: Right Drug, Right Time, Right Dose

Personalized Medicine: Right Drug, Right Time, Right Dose

Posted 01 March 2011 | By Robert O’Donnell, PhD

From 1950 to 2008 the US Food and Drug Administration (FDA) approved 1,222 new drugs (new molecular entities (NMEs) or new biologics).1 Approved labeling for the vast majority of these medicines (except for dosage adjustments due to renal or liver function or sex or racial differences) assumes patients are a single, homogeneous group and all will respond in the same way to any given dose-the "one size fits all" approach.

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