2022-21811: Facility Readiness: Goal Date Decisions Under Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Facility Readiness: Goal Date Decisions Under GDUFA." This draft guidance provides information to applicants on how FDA will use information related to a facility's readiness for inspection as certified on Form FDA 356h to set a goal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) submitted under the Federal Food, Drug, and Cosmetic Act. 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).
The agency’s own summary, as published.
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