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CONCEPT PAPER

PDUFA Pilot Project: Proprietary Name Review - Concept Paper October 2008

Download the Final Concept Paper Read the Federal Register Notice
Final
Docket Number:
FDA-2008-N-0281
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85, 121 Stat. 823 (FDAAA), which includes the reauthorization and expansion of the Prescription Drug User Fee Act (PDUFA IV).

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