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October 01, 2012 (Vol. 32, No. 17)

FDASIA’s Impact on Novel IVDs

Though Not Revolutionary, New Act Could Offer Significant Benefits to In Vitro Diagnostic Firms

  • On July 9, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA significantly affects both pharmaceutical and device manufacturers. It has a direct impact on all in vitro diagnostic (IVD) manufacturers, and for IVD companies developing companion diagnostics, an indirect effect as ...

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