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Generics Industry Calls for Changes to GDUFA


June 18, 2015.

Prominent generic drug industry groups have called for major changes to the Generic Drug User Fee Act (GDUFA), reports Alexander Gaffney of raps.org this week.   FDA has asked for feedback on GDUFA, three years after it was launched under the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). Under the program, companies can pay a user fee to have their products reviewed quickly. For example, a company submitting an abbreviated new drug application (ANDA), reports Gaffney, must pay FDA $58,730.    The Generic Pharmaceutical Association (GPhA) responded with a complaint about how FDA has spent the money it's collected so far. "FDA still has $277 million in unused funds from the generic industry that could be applied to site inspections or approvals," it said.   The group added that in 2011 when GDUFA began, median review time to approval was at 30 months. In 2012 it increased to 31 months and in 2014 is estimated to be 42 months. "At the industry's best estimate," said the group, "current fiscal year median approval times will be 48 months - the slowest it has ever been."   For more information on this story, click here

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