USA – FDA finalizes guidance giving abbreviated new drug application (ANDA) facilities time to comply with cGMP
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.
More information on the Regulatory Focus Website.
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vroby (19 octobre 2024). USA – FDA finalizes guidance giving abbreviated new drug application (ANDA) facilities time to comply with cGMP. ELSIBI. Consulté le 12 octobre 2026 à l’adresse https://doi.org/10.58079/12j9z
