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# Generic Drug Facility Readiness Inspection Guide
- URL: https://www.fdaweb.com/generic-drug-facility-readiness-inspection-guide/
- Published: 2024-06-17T12:00:00.000Z
- Updated: 2026-09-14T14:33:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157195

FDA has released a [final guidance](https://www.fda.gov/media/162018/download?ref=fdaweb.com) entitled “Facility Readiness: Goal Date Decisions Under GDUFA” that provides information on how the agency intends to assign a generic drug ANDA goal date based on a facility’s readiness for inspection. The document explains how FDA deals with a “program enhancement” agreed upon by the agency and industry as part of the generic drug user fee negotiations. “FDA may not be able to complete substantive assessment of an application unless all facilities are ready for inspection,” it says. “Therefore, this change helps FDA to focus resources on substantially complete applications that contain facilities ready for inspection.”