Generic Drug User Fee Amendments | FDA

Generic Drug User Fee Amendments | FDA





FDA requests notification of stakeholder intent to participate in consultation meetings on GDUFA Reauthorization

The U.S. Food and Drug Administration is requesting all stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2017 (GDUFA). 

In September 2022, new legislation will be required for FDA to continue collecting generic drug user fees for subsequent fiscal years for the generic drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA continue discussions with patient and consumer advocacy groups at least monthly during the Agency’s negotiations with regulated industry. Stakeholder meetings are expected to begin in October 2020 and will be held virtually each month.

The purpose of this notification request is to ensure continuity and progress in the monthly discussions by establishing consistent stakeholder representation. Interested stakeholders should submit their notification of intent to participate in these series of meetings by October 8, 2020 to GenericDrugPolicy@fda.hhs.gov.

Stakeholders should include their complete contact information, including: name, title, affiliation, address, email address, phone number, and notice of any special accommodations required because of disability in their notification of intent. Stakeholders will receive confirmation and additional information about the first meeting after FDA receives this notification. The meeting agendas, minutes, and any other updates will be posted to FDA’s GDUFA website as they become available.