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  • Marianne Calilhanna

What is GDUFA?

The Generic Drug User Fee Act (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public, and reduce costs to industry.

  • Up until October 2012, the law only required user fees for firms submitting new drug applications (NDAs).

  • As of October 1, 2012, under GDUFA, all firms that manufacture human generic drug products, and active ingredients for human generic drug products, that are distributed in U.S. commerce are subject to FDA user fees.

  • GDUFA fees increase the ability of the Agency to perform critical program functions and to reduce costs considering the reduced review timelines.

DCL Can Help

DCL’s Generic Self-Identification Service is available for preparing and submitting generic self-identification files for fiscal year 2025. The generic drug facility self-identification reporting period for fiscal year 2025 began on May 1, 2024. The reporting is required only for facilities involved in manufacturing generic drugs (such as those identified on an Abbreviated New Drug Application, ANDA) to determine their fees under the GDUFA Amendments of 2012.

For companies whose self-identification information has not changed since your last submission, just contact us. We will ask that you send us the last file successfully submitted and request that we update the file for a fiscal year 2025 submission. Even if your last submission was made earlier in 2024, you must submit again on or after May 1, 2024.

DCL’s professional team offers comprehensive services that relate to regulatory filings with the FDA. As an active member of the SPL Working Group and an industry leader with the management of complex reporting requirements for pharma and health sciences organizations, we can help navigate this process and the impending deadlines.

Have a question related to SPL or DCL's other services? Click the link below, we are happy to help.



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