FDA report delves into personalized medicine

New report details FDA's efforts to regulate growing field

SILVER SPRINGS, Md. — Earlier this year, the Food and Drug Administration approved a new drug for treating cystic fibrosis for patients who have a specific genetic mutation, but that also treats the underlying cause of the disease rather than the disease itself.

That drug, Vertex Pharmaceuticals' Kalydeco (ivacaftor), along with cancer drugs for patients whose tumors have specific genetic characteristics identified by a companion diagnostic test, are examples of personalized medicine. Personalized medicine, in which medical treatments are tailored to patients' individual characteristics, is a growing field and the subject of a new report by the FDA designed to provide a framework for regulating it.

"For the first time, it provides a compendium of FDA’s many recent efforts to advance regulatory standards, methods and tools in support of personalized medicine and to further refine critical regulatory processes and policies in order to bring about personalized medical product development," FDA commissioner Margaret Hamburg wrote in a forward to the report.


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