The FDA issued a new guidance on the use of “alternative tools” for assessing manufacturing facilities as part of the drug and biologics approval process. This guidance, titled “Alternative Tools for Assessing Manufacturing Facilities Named in a Marketing Application: Questions and Answers”, marks an important step in how FDA plans to balance its regulatory oversight with industry needs for efficiency, predictability, and flexibility.

For life sciences organizations preparing for approval, this guidance carries significant implications. Below we break down what has changed, why it matters, and how companies can best prepare.

What Are “Alternative Tools”?

Traditionally, FDA has relied on in-person, on-site inspections of manufacturing facilities when reviewing new marketing applications (NDAs, BLAs, ANDAs). These inspections serve to verify data integrity, confirm compliance with cGMP requirements, and evaluate overall manufacturing readiness.

However, in recent years FDA has begun incorporating additional mechanisms, especially during the COVID-19 pandemic when travel restrictions limited on-site inspections. The new guidance formalizes the use of several alternative tools, including:

• Remote Regulatory Assessments (RRAs): Non-inspection activities where FDA remotely evaluates records, data, or operations.

• Remote Interactive Evaluations: Virtual tours and live interactions with facility staff conducted via secure video.

• Reliance on Trusted Foreign Regulatory Partners: Accepting inspection reports or assessments from other regulatory authorities with which FDA has established confidentiality agreements.

• Documentary Evidence Submissions: Comprehensive records packages that allow FDA to verify readiness without an in-person visit.

Why Did FDA Issue This Guidance Now?

Two main drivers explain the timing:

1. Backlog of inspections: COVID-19 disruptions left FDA with a backlog of pre-approval and surveillance inspections. Alternative tools help the agency keep pace with growing application volumes.

2. Globalization of supply chains: With many products manufactured or tested outside the United States, reliance on trusted foreign authority reports and remote evaluations improves efficiency and reduces redundancy.

This approach is also tied to FDA’s commitments under PDUFA VII and BsUFA III, which emphasize modernizing facility assessment processes while maintaining regulatory rigor.

What Does This Mean for Applicants?

For companies submitting NDAs, BLAs, or ANDAs, this guidance means that an FDA decision is less likely to be delayed solely due to the inability to conduct a timely on-site inspection. However, it also places new responsibilities on sponsors:

• Be inspection-ready earlier. With the possibility of remote assessments, FDA may request access to records sooner than expected. Having a clean, well-organized documentary package is essential.

• Invest in virtual capabilities. Facilities must ensure they can provide high-quality video tours, secure data access, and real-time responsiveness to FDA reviewers.

• Know your global partners. If FDA plans to rely on foreign inspection reports, companies must confirm that their partners’ facilities are inspected by regulators with which FDA has confidentiality agreements.

• Expect hybrid models. Even if alternative tools are used, FDA may still follow up with an in-person inspection.

Benefits and Risks

Benefits:

• Faster approvals by avoiding inspection-related delays.

• Reduced burden on facilities located outside the U.S.

• Clearer expectations for how remote tools will be applied.

Risks:

• Increased scrutiny of documentary submissions (any gaps or inconsistencies may raise red flags).

• Technical failures during virtual evaluations could compromise impressions.

• Reliance on foreign inspection reports may introduce uncertainty if other authorities’ standards differ.

How to Prepare

Organizations should consider taking the following proactive steps:

1. Perform mock remote assessments. Simulate a virtual FDA evaluation to identify gaps in connectivity, camera coverage, and data access.

2. Upgrade documentation systems. Ensure quality records, validation reports, and SOPs are easily retrievable and secure.

3. Train staff for remote interactions. Employees should be comfortable presenting processes on camera and answering questions in real time.

4. Map global inspection coverage. Verify that foreign facilities fall under jurisdictions FDA recognizes for reliance.

Final Thoughts

FDA’s embrace of alternative tools reflects a lasting shift in how manufacturing facility readiness is verified. For life sciences companies, this is both an opportunity and a challenge: approvals may proceed more efficiently, but only if firms can adapt to a more agile and transparent review process.

At QSN, we help organizations build inspection-ready systems, prepare comprehensive documentation, and manage both on-site and remote evaluations. As FDA continues to modernize its oversight, proactive preparation will be the key to avoiding costly delays and ensuring a smooth path to market. Please contact us to see how we can help.