FDA sets generic drug facility user fees; warns pay up or no US entry
This article was originally published in SRA
The US Food and Drug Administration on 16 January rolled out the industry user fee rates for fiscal year 2013 for facilities where generic finished dosage form (FDF) medicines and active pharmaceutical ingredients (APIs) are made – with regulators warning that companies that fail to pay up could have their applications snubbed and their products deemed misbranded and denied entry into the US1.
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