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Regulatory Focus™ > News Articles > Clearance and Approval Pathways for Diagnostics

Clearance and Approval Pathways for Diagnostics

Posted 01 March 2011

Personalized medicine is a rapidly evolving area as therapeutic decisions based upon single test results become more common. Physicians have always used personalized medicine as they try to fit a therapy to a patient; however, personalized medicine has been recently taken to a new level of application. Exploration of the biology of disease and treatment at the molecular level are enabling physicians to use patients' genetic and protein information to provide the right therapy to the right patient at the right time.

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