Drugmakers want clarifications on an updated draft guidance the US Food and Drug Administration (FDA) recently released on pre-submission facility correspondence (PFC) for generic drug applications.
In December, FDA revised its draft guidance on submitting PFCs for generic drug applicants seeking a priority review of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or an amendment to either submission type in line with the Generic Drug User Fee Amendments (GDUFA III) program. The process can be used by generic drug sponsors to get a priority review goal date for their submission, but the PFC must be submitted two months before they submit their premarket application. (RELATED: FDA revises ANDA facility correspondence draft guidance, Regulatory Focus 2 December 2022)
The draft guidance specifically reflects changes to the content, timing and assessment of a PFC within the ANDA program as agreed under GDUFA III. It describes the process generic drug applicants who want priority review should follow to provide complete and accurate facility information before submitting a priority original ANDA, PAS, PAS amendment or ANDA amendment…
