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On August 18, 2017, the Food and Drug Administration Reauthorization Act (FDARA) was signed into law, which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2022. GDUFA aims to fund FDA's generic drug program, while ensuring that consumers have timely access to safe, high-quality, affordable generic drugs. GDUFA allows FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA’s generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications.

New for 2018, FDA has allowed companies and their affiliates to be grouped together and counted as a single entity for the purse of assessing the agency's program fee. FDA defines "affiliate as a business entity that has a relationship with a second business entity, if directly or indirectly, one business entity controls or has the power to control, the other business entity; or a third party controls or has the power to control both of the business entities." The program fees will be assessed in three tiers, as follows:

  • Large (companies with 20 or more approved ANDAs);

  • Medium (companies with between 6 and 19 approved ANDAs); and,

  • Small (companies with 5 or fewer approved ANDAs).

The GDUFA fees have been updated as follows:

  • ANDA $171,823

  • Program

  • Large $1,590,792

  • Medium $636,317

  • Small $159,079

  • DMF $47,829

  • Facility

  • Domestic API $45,367

  • Foreign API $60,367

  • Domestic FDF $211,087

  • Foreign FDF $226,087

  • Domestic CMO $70,362

  • Foreign CMO $85,362

  • Backlog $17,434

  • PAS N/A

(CMO="Contract Manufacturing Organization")

You can find FDA's announcement in the Federal Register here:

IUVO Consulting helps companies comply with GDUFA requirements for self-identification and fee payment. Contact today for assistance.

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