Pharma/Fine Chemicals Roundup – August 28

MANUFACTURERS REQUIRE TO SELF-IDENTIFY UNDER GDUFA The U.S. FDA is establishing a new system for the electronic self-identification of generic industry facilities, sites, and organizations for the Generic Drug User Fee Act (GDUFA). GDUFA was signed into law by the U.S. president on July 9, 2012. The generic drug industry will pay about $1.5 billion over five years in return for faster and more predictable review of generic drug applications, according to the terms of GDUFA. This will help reduce drug shortages and bring drugs to the market faster. GDUFA will also...

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