Hamburg: FDA turns attention to lab-developed diagnostics

06/3/2013 | Forbes

The FDA could use its regulatory discretion to increase its scrutiny of laboratory-developed diagnostics, including those that are tools for personalized medicine, FDA Commissioner Dr. Margaret Hamburg said at a conference. Tests developed and offered by labs are becoming more complex, and the FDA wants to ensure that "the accuracy and clinical validity of high-risk tests are established before they come to market," she said.

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