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  1. Generic Drugs

Generic Drug Research Priorities & Projects

Each year, FDA consults with industry and the public to develop a list of regulatory science initiatives on generic drugs in accordance with the Generic Drug User Fee Amendments (GDUFA). These priorities are discussed and developed in public meetings and workshops and result in several awarded projects each year.

Research Priorities

GDUFA Regulatory Science Initiatives Public Workshops & Meetings

Scientific Workshops & Meetings

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Awarded Projects

GDUFA Implementation

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