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CDR SBA Webinar SeriesGDUFA II Overview Donald Paresis PerezDirectorBranch Chief, GenericsDivision of User Fee Management and Budget Formulation Office of Management Center for Drug Evaluation and
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What is gdufa ii overview?
Generic Drug User Fee Amendments (GDUFA) II overview is a summary of the fees and reporting requirements for generic drug manufacturers.
Who is required to file gdufa ii overview?
Generic drug manufacturers are required to file GDUFA II overview.
How to fill out gdufa ii overview?
GDUFA II overview can be filled out online through the FDA's electronic submission portal.
What is the purpose of gdufa ii overview?
The purpose of GDUFA II overview is to ensure adequate funding for the FDA's review of generic drug applications.
What information must be reported on gdufa ii overview?
GDUFA II overview must include information on the number of generic drug applications submitted, the fees paid, and any changes in manufacturing facilities.
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