FDA Warns Generics Makers To Yank Defunct Applications

Law360, New York (August 22, 2012, 6:39 PM EDT) -- The U.S. Food and Drug Administration on Wednesday warned drugmakers to withdraw defunct applications for generic medications, or else pay a new “backlog fee” that could cost around $25,000 per application.

The FDA is charging the one-time fee, part of the new generic drug user fee agreement, in order to help it reduce the sprawling backlog of generic drug applications, known as abbreviated new drug applications or ANDAs. Generics makers will have to pay a fee for each pending application that has not yet won tentative...
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