FDA Warns Three Foreign Drug Cos. of Consequences for Non-Payment of Fees
The Food and Drug Administration recently sent warning letters to three pharmaceutical companies that are delinquent on generic drug user fees. FDA says Cataire Chimie of France (here), Korea United Pharm of South Korea (here), and Explora Laboratories of Switzerland…
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(here) have not yet paid 2013 or 2014 fees required by the Generic Drug User Fee Amendments of 2012. As a result, any drugs or active pharmaceutical ingredients from the companies may be misbranded, and FDA may place them on import alert if the fees aren’t paid. A full list of companies in arrears on generic drug user fees is (here).