The FDA has issued final guidance titled “ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.” It outlines the facility details required in a pre-submission facility correspondence (PFC) for priority abbreviated new drug applications (ANDAs). This guidance helps the FDA set review goals and reflects enhancements from the GDUFA III reauthorization agreement for 2023–2027. It finalizes the draft guidance released in December 2022