Edward S. Price, PCI Synthesis11.17.15
If we did a report card on the Generic Drug User Fee Amendments (GDUFA) of 2012, at best, it might get a C. In the three years since Congress voted for GDUFA, naysayers and supporters can both claim to have been right—on some aspects of the law. For example, GDUFA was intended to speed approvals to provide access to safe and effective generic drugs to the public, and we’re starting to see speedier approvals. GDUFA was also supposed to reduce costs to the industry, but we’ve seen just the opposite happen. And while the law has increased inspections, both of domestic and international manufacturers, to ensure foreign facilities meet U.S. standards, and to maintain public trust—the number of enforcement recommendations has not increased. Overall, while we’ve seen some important improvement because of GDUFA, there is much progress to be achieved.
Speed Approvals
In terms of approvals, the first thing to look at is the number of ANDA submissions. According to the FDA/GphA Quarterly Meeting in March 2015, the number of Abbreviated New Drug Applications (ANDA) has increased significantly from 885 i
Speed Approvals
In terms of approvals, the first thing to look at is the number of ANDA submissions. According to the FDA/GphA Quarterly Meeting in March 2015, the number of Abbreviated New Drug Applications (ANDA) has increased significantly from 885 i
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