Navigating FDA User Fee Updates for Fiscal Year 2023

September 29, 2023

As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs (including small molecules, vaccines, cell and gene therapy products, biologics, etc.), Generic Drugs, Biosimilars, and Medical Devices. In this context, ProPharma would like to bring attention to these updates for our clients, colleagues, and contacts.

Given that most user fee updates entail fee increases, now is an opportune time for all FDA-regulated companies to assess their eligibility for user fee waivers or discounts. A common example: drug sponsors with FDA Orphan Drug Designations qualify for a PDUFA fee waiver. Specifically, NDAs (New Drug Application) and BLAs (Biologics License Applications) associated with development programs that have received Orphan Drug Designations are exempt from PDUFA fees unless the NDA/BLA includes an indication other than the rare disease or condition addressed in the Designation. To be eligible for the exemption, the drug sponsor must also have received less than $50 million in gross worldwide revenue during the year prior to requesting for the exemption. It's important to note that this represents just one instance among several potential opportunities for fee waivers and discounts, all of which merit consideration. The table below summarizes some of the key fee updates for Fiscal Year 2023.

Key Highlights

FDA User Fee Type

FY2023 Fee Rate

FY2023 Fee Rate

Prescription Drug User Fee Amendment (PDUFA VII)
Application requiring clinical data $3,242,026 $3,117,218
Application not requiring clinical data $1,621,013 $1,558,609
Program Fee $393,933 $369,413
Generic Drug User Fee Amendment (GDUFA III)
Abbreviated new drug application (ANDA) $240,582 $225,712
Drug Master File (DMF) $78,293 $74,952
Active pharmaceutical ingredient (API) – Domestic $37,544 $42,557
API – Foreign $52,544 $57,557
Finished dosage form (FDF) – Domestic $213,134 $195,012
FDF – Foreign $228,134 $210,012
Contract manufacturing organization (CMO) – Domestic $51,152 $65,004
CMO – Foreign $66,152 $80,004
GDUFA program:
Large size operation generic drug applicant $1,620,556 $1,536,856
Medium size operation generic drug applicant $648,222 $614,742
Small business operation generic drug applicant $162,056 $153,686
Biosimilar User Fee Amendment (BSUFA III)
Initial biological product development (BPD) $47,325 $57,184
Annual BPD $47,325 $57,184
Reactivation $94,650 $114,368
Applications requiring clinical data $1,746,745 $1,746,745
Program $304,162 $304,162
Medical Device User Fee Amendment (MDUFA V)
Premarket approval (PMA) or Biologics License Application (BLA) standard fee $441,547 $374,858
Premarket approval (PMA) or Biologics License Application (BLA) small business fee $110,387 $93,714
Premarket report standard fee $441,547 $374,858
Premarket report small business fee $110,387 $93,714
Efficacy supplement to an approved BLA standard fee $441,547 $374,858
Efficacy supplement to an approved BLA small business fee $110,387 $93,714
Panel-track supplement standard fee $353,238 $281,143
Panel-track supplement small business fee $88,309 $70,286
De novo classification request standard fee $132,464 $112,457
De novo classification request small business fee $33,116 $28,114
180-day supplement standard fee $66,232 $56,229
180-day supplement small business fee $16,558 $14,057
Real-time supplement standard fee $30,908 $26,240
Real-time supplement small business fee $7,727 $6,560
510(k) standard fee $19,870 $12,745
510(k) small business fee $4,967 $3,186
30-day notice standard fee $7,065 $5,998
30-day notice small business fee $3,532 $2,999
513(g) request for classification information standard fee $5,961 $5,061
513(g) request for classification information small business fee $2,980 $2,530
Annual fee for periodic reporting on a Class III device standard fee $15,454 $13,120
Annual fee for periodic reporting on a Class III device small business fee $3,864 $3,280
Annual establishment registration fee standard fee $6,493 $5,672
Annual establishment registration fee small business fee $6,493 $5,672

To summarize:

Fiscal Year 2023 introduces varied changes in FDA User Fees, reflecting the dynamic landscape of the pharmaceutical, biologics, and medical device domains. Staying well-informed is paramount for industry professionals and organizations as they navigate these financial adjustments. As the FDA continues to prioritize healthcare product safety and efficacy, user fees remain essential in supporting these endeavors.

For precise insights into how these fee changes may affect your organization or submissions, consult the official FDA guidance and regulatory experts. ProPharma, leveraging its extensive regulatory expertise, stands ready to assist you in comprehending the updated fee structure and crafting strategies that seamlessly adapt to these changes. Our collective efforts ensure that the FDA can continue to fulfill its crucial mission of safeguarding public health while fostering innovation in the ever-evolving healthcare sector.

Take proactive steps today; contact ProPharma for personalized guidance and stay ahead of the curve.


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