This guidance provides information to applicants on how FDA intends to assign a goal date based on a facility’s readiness for inspection as certified on Form FDA 356h submitted as part of an original abbreviated new drug application (ANDA)under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).
This guidance explains how FDA 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), as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027” (GDUFA III commitment letter).
Under the commitment letter related to the GDUFA authorization for fiscal years 2018 through 2022 (under the Generic Drug User Fee Amendments of 2017), a goal date was assigned without regard to facility readiness.
In the GDUFA III commitment letter, FDA agreed to incorporate facility readiness into goal date assignment, such that FDA generally assigns a month goal date and defers substantive assessment if a facility is not ready for an inspection.
A number of GDUFA III commitments are intended to reduce first assessment cycle facility related delays that could delay application approval. The commitment outlined in this guidance sets the goal date to 15 months for an original ANDA containing a certification that a facility on Form FDA 356h is not ready for inspection. An applicant can amend its original ANDA to reset the 15-month goal date to a standard or priority assessment goal, as applicable, once all facilities become ready for inspection. However, the commitment letter also explains that for an application that continues to include a facility not ready for inspection 30 days before the 15- month goal date expiration, FDA will reset the goal date for an additional 15 months (i.e., 30 months from the date of original ANDA submission). FDA agreed to assess and act on 90 percent of such ANDAs within 30 months of the date of the original submission as applicable.
FDA considers a facility that is ready for inspection to be one that complies with current good manufacturing practice (CGMP) requirements and meets the following criteria related to the application product:
- 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
FDA may not be able to complete substantive assessment of an application unless all facilities are ready for inspection. Therefore, this change helps FDA to focus resources on substantially complete applications that contain facilities ready for inspection.
This guidance does not apply to:
- Facilities involved in bioequivalence and clinical studies used to support an application
- Amendments submitted after a complete response or tentative approval letter
- Supplements or amendments to a supplement
Related: Self Identification of Generic Drug Facilities, Sites, and Organizations
