Both GDUFA and PDUFA are US FDA’s User Fee
programs, which help FDA to hire and retain sufficient numbers and types of
technical and scientific experts to efficiently conduct reviews of
human drug applications (NDA and ANDA) and improving the predictability of
review processes. GDUFA is related to ANDAs whereas PDUFA is related to NDAs.
GDUFA: Generic Drug User
Fee Amendments. The Generic Drug User Fee Act is a law designed to speed access
to safe and effective generic drugs to the public, and reduce costs to industry.
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