FDA raises generic drug user fees for 2014

WASHINGTON — The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.

According to the Federal Register, the daily journal of the U.S. government, the FDA announced new rates for the abbreviated new drug application (ANDA), prior approval supplement to an approved ANDA (PAS), drug master file (DMF), generic drug active pharmaceutical ingredient (API), and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program.

The new fee for an ANDA is now set at $63,860, up approximately 24% from the current $51,520. The PAS will similarly be raised by 24%, to $31,930. The FDF fee increased to $220,152, a jump of 25%. The largest percent increase hit the DMF fee, which rose nearly 48% to $31,460. However, the API fee was lowered to $34,515.


- 9:04 AM
peninam says

FDA now refunds 75% of the original filing fee in all instances of refuse-to-receive with the exception of failure to pay fees. Therefore, an application that is refused on the first attempt, amended, refiled and accepted for review would pay a total of $78,825, or 125% of the standard amount. - Penina Mezei Americare

Login or Register to post a comment.