On July 31, 2024 the U.S. Food and Drug Administration (FDA) recently published in the Federal Register notice (FRN) the User Fee Rates for Fiscal Year 2025. The U.S. Food and Drug Administration (FDA) implements several user fee programs such as Generic Drug User Fee Amendments (GDUFA), Biosimilar User Fee Amendments (BSUFA), Over-the-Counter Monograph Order Request (OMOR), and Medical Device User Fee Amendments (MDUFA) that are designed to support its regulatory activities and ensure the timely review and approval of various medical products.
These rates represent an increase from the previous fiscal year, reflecting adjustments for inflation and the increased costs associated with FDA review processes. These fees are effective on October 1, 2024, and will remain in effect through September 30, 2025. For applications that are submitted on or after October 1, 2024, the new fee schedule must be used.
Generic Drug User Fee Amendments (GDUFA) aim to expedite the availability of generic drugs by providing the FDA with additional resources.
The fees collected under GDUFA help fund the review of generic drug applications (Abbreviated New Drug Applications or ANDAs), inspections, and other related activities. These fees support efforts to reduce application backlogs, improve the predictability of review times, and enhance overall communication with the industry.
For more detailed information on the Generic Drug User Fee Rates for FY 2025, including fee waivers, refunds, and exemptions, please refer to this LINK.
Biosimilar User Fee Amendments (BSUFA) support the FDA's review process for biosimilar products, which are highly similar to or interchangeable with an already FDA-approved biological product.
The fees collected under BSUFA are used to expedite the FDA's review of biosimilar applications, which helps bring more affordable biosimilar products to the market. The FY 2025 base revenue amount is to be adjusted by the inflation adjustment, strategic hiring and retention adjustment, capacity planning adjustment (CPA), operating reserve adjustment, and the additional dollar amount.
The Over-the-Counter Monograph Order Request (OMOR) program is part of the FDA's Over-the-Counter Monograph Drug User Fee Program, introduced under the CARES Act. It provides a mechanism for the FDA to review and approve updates to OTC drug monographs, such as adding new ingredients or modifying labeling.
There are two levels of OMOR fees, based on whether the OMOR at issue is a Tier 1 or Tier 2 OMOR.
Tier 1 OMORs involve significant changes to the OTC drug monograph. These changes can include the introduction of new active ingredients, new dosage forms, new routes of administration, or new conditions of use (such as a change in the intended use of the product).
Tier 2 OMORs generally involve less significant modifications. These can include changes that do not significantly affect the product's formulation or use, such as minor labeling changes that do not involve new uses or new claims, or modifications that are administrative in nature.
Medical Device User Fee Amendments (MDUFA) MDUFA aims to ensure that safe and effective medical devices reach the market in a timely manner.
The fees collected help fund the FDA's review process for premarket submissions, including premarket approval (PMA) applications, premarket notifications (510(k)), and other device-related submissions.
MDUFA V directs FDA to use the yearly total revenue amount as a starting point to set the standard fee rates for each fee type. The fee is classified in to two types
Standard Fee: The fee applicable to regular-sized medical device manufacturers or those not classified as small businesses.
Small Business Fee: A reduced fee rate applicable to medical device manufacturers that meet the criteria for a small business, as defined by the FDA.
The adjusted user fee rates for FY 2025 are a key part of ensuring the FDA's ability to continue providing timely and effective regulatory review services for medical devices. For a complete list of the new fee rates and detailed information, please refer to the Federal Register notice.
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