The US Food and Drug Administration (FDA) will give generic drug manufacturers more time to bring facilities not fully compliant with its current good manufacturing practice (cGMP) requirements up to speed. The agency’s objective is to reduce first assessment cycle facility-related delays, ultimately leading to delayed approvals for premarket applications, and incentivize sponsors not fully ready to submit their applications.
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…
