USA – FDA revises ANDA facility correspondence draft guidance

The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking a priority review of their abbreviated new drug application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 Amendment (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. The original version of the guidance was published in June 2017 and revised shortly thereafter in November 2017. (RELATED: Priority Generic Drug Reviews: New FDA Draft GuidanceRegulatory Focus 19 June 2017)

The new guidance reflects changes to the content, timing and assessment of a PFC within the ANDA program as laid out 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…