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 app...