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# Leverage FDA ‘Alternative Tools’ Flexibility: Attorneys
- URL: https://www.fdaweb.com/leverage-fda-alternative-tools-flexibility-attorneys/
- Published: 2025-09-18T12:00:00.000Z
- Updated: 2026-09-14T15:22:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159889

In a white paper explaining FDA’s 9/12 [guidance](https://www.fdaweb.com/alternative-facility-assessment-tools-guidance/) on using alternative tools to assess drug manufacturing facilities identified in pending applications, three Sidley attorneys [say](https://www.sidley.com/en/insights/newsupdates/2025/09/fdas-alternative-tools-guidance-promises-a-flexible-approach-for-manufacturing-facility-assessments?ref=fdaweb.com) U.S. companies “can and should leverage the flexibility of these alternative tools to streamline regulatory timelines and approval pathways.” They also say that manufacturing facilities should modernize their approaches to inspection readiness to navigate the evolving regulatory environment.

“Companies should develop internal protocols to manage FDA requests efficiently, train staff for virtual engagements, and maintain open lines of communication with regulators,” the paper says. “While this guidance provides valuable flexibility, it also imposes new compliance obligations that require proactive planning.”

The attorneys say that with the guidance, FDA is explicitly affirming that tools beyond the traditional on-site preapproval or pre-license inspection can support facility evaluations for pending applications. The tools include remote regulatory assessments, trusted foreign partner inspections, and remote subject matter experts.

The paper raises these legal and regulatory considerations:

- obligations under records requests;
- voluntary vs. mandatory participation;
- global harmonization; and
- transparency and technology.

The attorneys conclude that the guidance “is an important development for companies seeking approval for manufacturing facility-related applications.” They say it is no accident that the agency published it shortly after announcing the Pre-Check program and the Commissioner’s Priority Review Voucher program. “FDA is looking to streamline the application review process, especially for new manufacturing facilities in the U.S.,” they say.