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# Drug Manufacturing Alternative Assessment Tools
- URL: https://www.fdaweb.com/drug-manufacturing-alternative-assessment-tools/
- Published: 2023-09-21T12:00:00.000Z
- Updated: 2026-09-14T18:57:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155383

FDA has published a draft guidance, *Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications*, giving applicants information on how the agency intends to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 manufacturing facilities identified in an NDA, ANDA, BLA, or supplements to any of those applications. The [document](https://www.fda.gov/media/172290/download?ref=fdaweb.com) says it does not apply to other drug inspection programs including postapproval inspections, surveillance inspections, follow-up and compliance inspections, and bioresearch monitoring inspections.

Under the PDUFA 7 agreement, FDA says, the agency agreed to issue a guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from using such tools during the Covid-19 pandemic.