FDA announces new GDUFA fees and says to pay up by Oct. 1

The FDA has published its GDUFA facility fees for generic drugmakers for its next fiscal year, which are due on Oct. 1, in the Federal Register. Using formulas it lays out in the publication, the FDA says it ended up with a domestic API facility fee of $40,867 and foreign API facility fee of $55,867. For finished dosage forms, the fees are $243,905 for a domestic facility and $258,905 for a foreign facility. The foreign facility fees are $15,000 more in each case. Notice

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