FDASIA’s Impact on Novel IVDs

Though Not Revolutionary, New Act Could Offer Significant Benefits to In Vitro Diagnostic FirmsOctober 1, 2012

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 well through FDASIA’s numerous provisions relating to drugs.

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