FDAnews Announces — Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks

For generic drugmakers, Oct. 1 is crunch time, the date after which all ANDA amendment and prior-approval supplement applications must meet new performance goals under the Generic Drug User Fee Amendments (GDUFA) of 2012. Joan Janulis, a Hatch-Waxman pro and all-around expert on FDA regulation in the generic drug industry, will help attendees read between the lines of the GDUFA performance metrics, associated guidance documents and MAPPs, and provide a roadmap to the post-GDUFA paradigm. Falls Church, VA (PRWEB) September 30, 2014 Impact of GDUFA Performance Metrics on ANDA Approval Times:
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