The FDA is announcing the availability of a revised draft guidance for industry, ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions. The FDA revised the Pre-Submission Facility Correspondence (PFC) process as part of the performance goals and program enhancements the FDA and industry agreed to in Generic Drug User Fee Amendments of 2022 (GDUFA III). This guidance describes the content, timing, and assessment of a complete and accurate PFC.
The FDA assesses facility information submitted in a PFC to inform the Agency's decision on the need for facility and site inspections that support assessment of an abbreviated new drug application (ANDA). A complete and accurate PFC allows the FDA to begin the facility and site assessment process in advance of the planned ANDA submission for priority ANDAs, allowing the Agency more time to make preapproval inspection decisions. A PFC that meets the conditions outlined in this guidance will qualify the ANDA for a shorter, 8-month priority review goal. This guidance also provides information on the Agency's rationale for and current approach to assessing a PFC and replaces the previous draft guidance issued in November 2017. Learn more at the ANDA Assessment Program – GDUFA III Performance Goals and Program Enhancements website.
For additional information, please view a pre-recorded presentation on this revised draft guidance.
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