7:56 PM
Jun 03, 2013
 |  BC Extra  |  Politics & Policy

FDA planning to issue LDT guidance

FDA has drafted a guidance document that lays out its plans for regulating laboratory-developed tests, FDA spokesperson Susan Laine told BioCentury on Monday. The agency is "proposing to regulate all in vitro diagnostic tests in the same risk-based framework the agency currently uses, whether or...

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