RAPS: As FDA Tries to Regulate Lab-Developed Tests, Congress Signals Potential Opposition

On 1 August 2014, FDA released a new draft guidance document, Framework for Regulatory Oversight of LDTs, that proposes regulating LDTs more or less like IVDs. Under FDA\'s proposed regulatory framework, moderate-risk LDTs will be required to be registered and listed with FDA, meet adverse event reporting standards and undergo premarket review starting five years after the guidance is implemented.

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