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USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug

Earlier today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions".

Pre-Submission Facility Correspondence “PFC” refers to a submission of facility information prior to ANDA submission that enables a shorter review goal (priority review goal) for certain priority original ANDAs, PASs, PAS amendments, and ANDA amendments, if the PFC meets applicable conditions.

In this revised draft guidance, references to the terms of the GDUFA III commitment letter are referenced, and suggestions are provided for the content, timing, and assessment of PFCs for priority ANDAs, so that the ANDA will be eligible for priority review under the commitment letter's provisions.

This guidance also provides information regarding FDA’s assessment process for a PFC. Specifically, the guidance describes:

  1. the content and format of the facility information that should be submitted to enable FDA’s assessment of facilities listed in the PFC;

  2. timeframes for the PFC, and the intersection of these timeframes with the submission of an ANDA;

  3. the possible outcomes of the Agency’s assessment of a PFC; and,

  4. when and how the Agency communicates with an applicant about receipt of the PFC and assignment of a goal date for the ANDA.

In order to qualify for a priority review goal, an applicant should submit a PFC no later than days prior to the date of ANDA submission.

The complete and accurate PFC must be submitted in the electronic common technical document (eCTD) format.


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