Business · 05/12/2022

FDA Announces Revised Draft Guidance for Industry on Pre-Submission Facility Correspondence for Prioritized Generic Drug Submissions

The US Food and Drug Administration (FDA) has released a revised draft guidance for industry on the Pre-Submission Facility Correspondence (PFC) process, which aims to streamline the review of abbreviated new drug applications (ANDAs) for generic drugs. The new guidance, part of the Generic Drug User Fee Amendments of 2022 (GDUFA III), will help the FDA assess facility information to inform inspection decisions and potentially qualify ANDAs for a shorter review period.