FDA Details When It Won't Accept Generic Drug Applications

Law360, New York (October 1, 2013, 3:05 PM EDT) -- The U.S. Food and Drug Administration on Monday issued guidance on circumstances that will result in its refusing to review applications for approval of generic drugs, including unpaid user fees and proposed labeling that implicates another company’s patents.

While much of the “refuse to receive” guidance is not new, provisions covering outstanding payments are emerging as a result of last year’s Generic Drug User Fee Amendments. Under the guidance, an application won’t be accepted if a drugmaker fails to pay fees within 20 days of applying. In...
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