Facility Readiness: Goal Date Decisions Under Generic Drug User Fee Amendments; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Facility Readiness: Goal Date Decisions Under GDUFA." This guidance provides information to applicants on how FDA will use information related to a facility's readiness for inspection as certified on Form FDA 356h to set a goal date for an original abbreviated new drug application (ANDA). This guidance incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA) and as described in "GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027" (GDUFA III commitment letter). This guidance finalizes the draft guidance of the same title issued on October 7, 2022.
Abstract as published in the Federal Register.
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