> ## 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.

# Draft Guide on ANDA Pre-submission of Facility Information
- URL: https://www.fdaweb.com/draft-guide-on-anda-pre-submission-of-facility-information/
- Published: 2017-11-03T12:00:00.000Z
- Updated: 2026-09-14T23:00:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140045

FDA has posted a revised [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM563507.pdf?ref=fdaweb.com) on “ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence).” It describes the process for generic drug applicants to pre-submit complete, accurate facility information in advance of a priority ANDA, prior approval supplement, or amendment under the Generic Drug User Fee Amendments of 2017.

The recent FDA Reauthorization Act simplified the process for preparing and submitting such information set out in an earlier version of the guidance. It lists the ANDA sections containing facility information that the agency will review to determine whether inspections will be necessary for the facilities identified in the pre-submission. “All the facility information listed in the revised draft guidance is information the FDA typically considers during the early stages of review when determining whether inspections are needed for manufacturing facilities and bioequivalence and clinical testing sites and organizations,” the document says.