FDA finalizes guidance giving ANDA facilities time to comply with cGMP

[Editor's Note: This article was updated 6 July to clarify FDA's intention with the final guidance.]

The US Food and Drug Administration (FDA) has provided details on how it intends to assign a goal date based on a facility’s readiness for inspection, which includes information for generic drug manufacturers on how to determine when facilities associated with an application will be ready for inspection in support of an original abbreviated new drug application (ANDA). The agency said its objective is to reduce first assessment cycle facility-related delays, ultimately leading to delayed approvals for premarket applications, as well as incentivize the submission of applications that include facilities ready for inspection to facilitate their timely substantive assessment.

FDA has finalized a guidance that allows manufacturers to get an inspection extension for some facilities that are not fully cGMP compliant. The extension is part of an agreement between the agency and industry under the Generic Drug User Fee Amendment (GDUFA III). It states that sponsors of abbreviated new drug applications (ANDA) who state on their Form FDA 356h that they have a facility not ready for inspection will get 15 months to bring that facility into compliance.

“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,” according to the guidance. “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).”

Based on the GDUFA III agreement, FDA agreed to include facility readiness as part of the goal date assignment. Typically, the agency would assign a 15-month goal date but defer substantive assessments if the sponsor reports that a facility isn’t ready for inspection when their ANDA is submitted. It also committed to assessing and acting on 90 percent of ANDAs, including Form 356h issues within 30 months of filing the original application.

“FDA may not be able to complete substantive assessment of an application unless all facilities are ready for inspection,” said the guidance. “Therefore, this change helps FDA to focus resources on substantially complete applications that contain facilities ready for inspection.”

“Through the implementation of this commitment, FDA and industry aim to incentivize the submission of applications that include facilities ready for inspection to facilitate their timely substantive assessment,” the guidance added.

FDA noted, however, that not all ANDA applications were eligible for the deferral. It said that facilities used to conduct bioequivalence and clinical studies to support the premarket application, ANDAs that include amendments after a complete response or tentative approval letter was sent to the sponsor, and those that contain supplements or amendments to a supplement don’t qualify for the 15-month grace period.

FDA published the draft version of the guidance in October 2022, and there were no significant changes to the final draft (RELATED: FDA issues guidances on facility readiness and early DMF assessments under GDUFA III, Regulatory Focus 4 October 2022).

Final guidance

FDA finalizes guidance giving ANDA facilities time to comply with cGMP

Related topics

Recommended content

Welcome to the new RAPS Digital Experience