President to Sign Food and Drug Administration Safety and Innovation Act: Summary of Certain Key Provisions

President Obama is expected to soon sign into law the Food and Drug Administration Safety and Innovation Act (FDASIA). When signed, FDASIA will reauthorize for another five years the Prescription Drug User Fee Act (PDUFA V) and the various related user fee agreements between the drug and device industries and the Food and Drug Administration (FDA). FDASIA includes provisions related to drugs, devices, generic drugs, and biosimilar biological products. The following is a summary of certain key provisions pertaining to innovator and, where specified, generic drugs and biosimilar biological products.

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