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FDA has increased its fees for drug approvals, reduces unit inspection charge

The US regulator FDAhas increased its fees for new generic drug applications by up to 30 percent and the fees for facility inspection of foreign companies have been reduced.

From October 1, the US Food and Drug Administration (USFDA) has increased the fee for Abbreviated New Drug Applications (ANDAs) to $76,030 from $58,730 currently.

According to a notification issued “For 2015-16, the generic drug fee rates are: ANDA $76,030, PAS $38,020, DMF $42,170, domestic API (active pharmaceutical ingredient) facility $40,867, foreign API facility $55,867, domestic FDF finished dosage form facility $243,905, and foreign FDF facility $258,905.”

“These fees are effective October 1, 2015, and will remain in effect through September 30, 2016.”

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