Pharma/Fine Chemicals Roundup – January 17

GENERIC DRUG USER FEE PROGRAM GOES TO CONGRESS The U.S. Food and Drug Administration (FDA) says it has completed its recommendations for the proposed generic drug user fee program (GDUFA). The recommendations were transmitted by the Department of Health and Human Services to Congress on January 13. GDUFA will require FDA to improve significantly its regulatory activities for the benefit of generic drug providers and U.S. generic drug consumers. The global generics industry, in exchange, will provide FDA with $299 million/year in user fees over the next five...

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