FDA sets generic drug user fee rates for 2013

Higher fees for foreign factories calculated based on self-identification process

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Wednesday.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

The fees for domestic factories making final dosage forms and active pharmaceutical ingredients are $175,389 and $26,458, respectively. For foreign factories, the fees are respectively $190,389 and $41,458.

The agency said that under the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, the fee for a factory outside the United States should be $15,000 to $30,000 higher than the fee for a domestic factory.

The FDA said it calculated the fee using data submitted by generic drug facilities through the self-identification process mandated under GDUFA.


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