IHS Chemical Week

Markets :: Fine Chemicals/Biotech :: Pharmaceutical ingredients

Pharma/fine chemicals roundup—16 April

10:08 AM MDT | April 16, 2013 | Deepti Ramesh

FDA’s self-identification process for 2014 begins in May The US FDA says that the generic drug facility self-identification reporting period for fiscal-year 2014 will begin on 1 May 2013 and close on 1 June 2013. Generic drug facilities, certain sites, and organizations identified in a generic-drug submission are required by the Generic Drug User Fee Amendments of 2012 (GDUFA) to submit, update, or reconfirm identification information to FDA annually, the agency says. GDUFA became effective on 1 October 2012. The worldwide generic drug industry will pay FDA...

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