FDA issues Guidance on Facility Readiness Goal Date Decisions

The guidance provides information on how FDA decides goal dates for a drug application (ANDA, BLA, NDA) based on information provided in the Form 356h regarding Facility readiness.

This is a program enhancement as described in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter). Earlier as per GDUFA authorisation from 2018 to 2022, goal date for a drug application was being assigned without regard to facility readiness.

Facility Readiness for Inspection

A Facility is ready for inspection when:

• Facility operations, methods, and product formulation are the same as those described in the application
• Data at the facility are complete and accurate, and are consistent with data in the application
• The facility is ready for commercial manufacturing

Goal date of 15 months when Facility Not Ready

In the Form 356h (Application to market a New or Abbreviated New Drug or Biologic for human use) in Section 28, applicant shall indicate Facility Readiness by selecting the appropriate checkbox Yes or No for the section Is the site ready for inspection. If Applicant checks Yes for all sites associated with an application, FDA will assign standard goal date (10 months from date of submission for standard original ANDA and 8 months for priority ANDA). However, if applicant checks No, then the goal date assigned shall be 15 months from date of original submission. For original applications the checkbox N/A shall not be checked. Checkbox N/A shall be checked only for withdrawing a facility from applications.

When an applicant has checked No for facility readiness FDA defers substantive assessment of the application until receipt of an amendment with an updated Form FDA 356h stating all facilities are ready for inspection. An applicant shall submit an amendment indicating all facilities are ready for inspection at least 30 days before the goal date. FDA will reassign the goal date, calculating from the amendment receipt date. If no amendment is submitted, the goal date will be reset for an additional 15months (30 months from date of original ANDA submission).

This guidance do not apply to BA/BE and clinical study facilities and to supplements and amendments.

Links:

• USFDA: Facility Readiness: Goal Date Decisions Under GDUFA
• USFDA: GDUFA III Commitment Letter