> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on ANDA Pre-Submission Facility Correspondence
- URL: https://www.fdaweb.com/guide-on-anda-pre-submission-facility-correspondence/
- Published: 2025-06-13T12:00:00.000Z
- Updated: 2026-09-14T15:14:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159357

FDA has released a [final guidance](https://www.fda.gov/media/187029/download?ref=fdaweb.com) entitled “ANDAs: Pre-Submission Facility Correspondence (PFC) Related to Prioritized Generic Drug Submissions.” The document describes and provides recommendations on the content, timing, and assessment of a PFC for a priority ANDA. It also provides information regarding FDA’s assessment process for a PFC. Specifically, the guidance describes:

- the content and format of the facility information that should be submitted to enable FDA’s assessment of facilities listed in the PFC;
- timeframes for the PFC, and the intersection of these timeframes with submission of an ANDA;
- the possible outcomes of the Agency’s assessment of a PFC;
- and, when and how the agency communicates with an applicant about receipt of the PFC and assignment of a goal date for the ANDA.