FDA Policy/General

User Fee Rates Set for FY 2026

FDA has posted the following user fee rates for fiscal year 2026 (effective 10/1). They are:

Prescription drugs and biologics: $4.682 million for an application requiring clinical data. This is an 8.6% increase in the current fee. The annual program fee is $442,213, which is a 9.5% decrease.
Biosimilars: $1.201 million for an application requiring clinical data, which is an 18.3% decrease in the current fee
Medical devices: $540,783 for a PMA application, which is a 7/1% increase over the current fee. The fee for a 510(k) is $24,335.
Generic drugs: $358,247 for an ANDA submission, which is an 11.3% increase in the current fee.

The links above are to the corresponding Federal Register notices detailing the fee structure for each program.

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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