USFDA Guidance: Alternative Tools for Facility Assessments in Pending Applications
- Sharan Murugan
- 35 minutes ago
- 2 min read
The U.S. Food and Drug Administration (FDA) has issued a final guidance on 11th September 2025 titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.” This guidance outlines how the Agency will use modernized methods, beyond traditional on-site inspections, to evaluate facilities referenced in drug marketing applications.
Drug applications—including NDAs, ANDAs, and BLAs—must demonstrate that all listed manufacturing facilities comply with current good manufacturing practice (CGMP) requirements. Historically, FDA has relied heavily on Pre-Approval Inspections (PAIs) and Pre-License Inspections (PLIs).
However, during the COVID-19 pandemic, FDA developed alternative tools to maintain regulatory oversight when physical inspections were not feasible. Building on that experience, this new guidance makes clear that these tools will remain part of FDA’s standard operations.
Key Highlights from the Guidance
1. Risk-Based Use of Alternative Tools
FDA will apply a risk-based framework to determine when alternative tools can be used in place of, or to support, inspections. Factors considered include:
Facility’s inspection history (FDA or trusted foreign regulator)
Complexity of manufacturing processes
Novel technologies or limited commercial experience
Public health urgency (e.g., shortages, critical therapies)
Travel restrictions or other feasibility concerns
2. Remote Regulatory Assessments (RRAs)
FDA may conduct Remote Regulatory Assessments (RRAs), where facilities provide records, documents, and live virtual demonstrations. These may include:
Requests for records under Section 704(a)(4) of the FD&C Act
Remote Interactive Evaluations (RIEs) via livestream, teleconferencing, or screen sharing
While responses to record requests are mandatory, participation in an RIE remains voluntary. Declining, however, could delay application review.
3. Leveraging Trusted Foreign Regulators
Through Mutual Recognition Agreements (MRAs) with the EU, UK, and Switzerland, FDA may rely on inspection reports and collaborate on joint or hybrid inspections. This reduces duplication, speeds global market access, and enhances efficiency.
4. Use of Remote FDA Subject Matter Experts (SMEs)
FDA may supplement on-site inspections with remote SMEs. These experts, connected virtually, can provide real-time input on specialized technical aspects such as sterile manufacturing or complex biologics processing.
5. Effects of Using Alternative Tools
Efficiency Gains: Helps FDA meet user fee review goals and make timely approval decisions.
Flexibility: Reduces delays caused by travel limitations or resource constraints.
Transparency: Written observations from RRAs or RIEs may be shared with facilities, requiring responses within 15 business days.
This guidance fulfills commitments under PDUFA VII and BsUFA III reauthorizations. It marks a permanent shift in regulatory practice—where digital tools, remote evaluations, and international collaboration play a central role in safeguarding drug quality while expediting patient access.
The FDA’s new guidance represents a forward-looking step in regulatory science. By institutionalizing the use of alternative tools—from RRAs to hybrid inspections—the Agency ensures resilience, adaptability, and efficiency in facility assessments. For industry, this underscores the importance of maintaining inspection readiness and digital transparency, even when regulators are not physically on site.
For more information, read the full FDA guidance: