2022-26412: Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Draft Guidance for Industry; Availability

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions." For purposes of implementing the Generic Drug User Fee Amendments of 2022 (GDUFA III), the Pre-Submission Facility Correspondence (PFC) process was revised as part of the performance goals and program enhancements agreed to by FDA and industry, as described in the GDUFA Reauthorization Performance Goals and Program Enhancements, Fiscal Years 2023 through 2027 (GDUFA III commitment letter). FDA assesses facility information submitted in a PFC to inform the Agency's decision regarding the need for facility inspections that support assessment of the abbreviated new drug application (ANDA). A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned ANDA submission for priority ANDAs, allowing the Agency more time to make preapproval inspection decisions. A PFC meeting the conditions outlined in the revised draft guidance will qualify the ANDA for a shorter, 8- month priority review goal. This revised draft guidance describes the content, timing, and assessment of a complete and accurate PFC for purposes of GDUFA III. Additionally, this revised draft guidance provides information on the Agency's rationale for and current approach to assessing a PFC and replaces the previous draft guidance for industry, "ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence)," issued in November 2017.

The agency’s own summary, as published.