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USFDA Guidance: Facility Readiness: Goal Date Decisions Under GDUFA

The US FDA has released final guidance for industry applicants "Facility Readiness: Goal Date Decisions Under GDUFA" which helps assign goal dates based on a facility’s readiness for inspection, as certified on Form FDA 356h as part of an original abbreviated new drug application (ANDA).  This is part of the Generic Drug User Fee Amendments (GDUFA) program enhancements under GDUFA III, aimed at improving the efficiency and timeliness of the generic drug approval process.

This guidance also provides recommendations on how applicants can determine whether a facility is prepared for inspection and how to include inspection readiness information on Form FDA 356h submitted with applications. FDA and industry agreed to enhance the program in the Generic Drug User Fee Amendments of 2022 (GDUFA III) in this guidance.

The FDA assigns a 15-month goal date if a facility is not ready for inspection at the time of application submission. The intention is to prioritize applications with facilities that are inspection-ready, ensuring a more efficient review process.

Applicants must evaluate whether each facility listed in their application is ready for inspection. A facility is considered ready if it complies with current Good Manufacturing Practice (CGMP) requirements and meets criteria related to the application product, including accurate and complete data and readiness for commercial manufacturing.

Form FDA 356h is used to provide facility information for manufacturing, packaging, and control sites. Applicants must indicate inspection readiness for each facility listed. The FDA will issue an information request (IR) letter if the inspection readiness section is incomplete or marked incorrectly. Failure to respond to this letter will result in a default 15-month goal date assignment.

Upon submission of an original ANDA with a completed Form FDA 356h, the FDA reviews the submission for facility readiness. Suppose any facilities are not ready for inspection. In that case, the FDA assigns a 15-month goal date and defers substantive assessment until an amendment is received with an updated Form FDA 356h indicating all facilities are inspection-ready. The goal date is then reassigned based on the amendment receipt date.

For more detailed information, refer to the full guidance document available on the FDA website: Facility Readiness: Goal Date Decisions Under GDUFA.


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