> ## 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.

# Alternative Facility Assessment Tools Guidance
- URL: https://www.fdaweb.com/alternative-facility-assessment-tools-guidance/
- Published: 2025-09-12T12:00:00.000Z
- Updated: 2026-09-14T15:21:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159856

FDA has published a guidance, *Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications*, giving applicants information on how the agency intends to use alternative tools to assess drug manufacturing facilities identified in NDAs, BLAs, ANDAs, or their supplements. The [document](https://www.fda.gov/media/172290/download?ref=fdaweb.com) meets a requirement in the PDUFA 7 and BsUFA 3 commitment letters that FDA issue guidance on using alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Covid-19 pandemic.

FDA says the guidance does not apply to other drug inspection programs, including postapproval inspections, surveillance inspections without preapproval or prelicense components, follow-up and compliance inspections, and bioresearch monitoring inspections.

The guidance includes an Introduction, Background, Risk-Based Use of Alternative Tools, Considerations for Alternative Tools, and The Effects of Using Alternative Tools.