FDA Policy/General

Generic Drug User Fee Rates for FY 2025

Federal Register notice: FDA is announcing fiscal year 2025 rates for generic drug user fees. They are:

ANDA — $321,920
Drug master file — $95,084
Active pharmaceutical ingredient (API) domestic facility — $41,580
API foreign facility — $56,580
Finished dosage form (FDF) domestic — $231,952
FDF foreign — $246,952
Contract manufacturing organization (CMO) domestic — $55,668
CMO foreign — $70,668
GDUFA program (large operation) —$1.9 million
GDUFA program (medium operation) — $756,666
GDUFA program (small operation) — $189,166

To view the notice, click here.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome