FDA Answers Questions related to User Fees for Generic Drugs

31/03/2013 22:48

FDA Answers Questions related to User Fees for Generic Drugs

From 2013 on generic drug and API manufactures must pay an annual users fee. Now FDA has disclosed the fee amounts on its website. A domestic FDF (fixed dose formula) facility has to pay: $175,389, foreign FDF facility: $190,389, domestic API facility: $26,458 and foreign API facility: $41,458. On the same website FDA also answers questions such as: "When will facility fees be due?", "Who is required to pay facility fees?", "Do two locations of the same company have to pay separate facility fees?", and "What is the penalty for failure to pay a facility fee?"

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