FDA lays out framework for regulating personalized drugs, devices

10/30/2013 | Medscape (free registration)

The FDA has issued a report detailing how it intends to regulate medical devices and drugs geared for specific patient subpopulations. FDA Commissioner Dr. Margaret Hamburg said the report "captures the broad context of what's happening in science and medicine today and the role of the FDA as we enter the era of personalized medicine, and for us, personalized medical product development."

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