News Brief: FDA Unveils New Tools to Evaluate Drug Manufacturing Sites

On October 29, 2025, the U.S.Food and Drug Administration (FDA) published a new industry guidance titled Alternative Tool: Assessing Drug Manufacturing Facilities Identified in Pending Applications. The document outlines how the FDA may increasingly rely on methods other than on-site inspections when evaluating manufacturing facilities listed in applications for new drugs, generics, and biologic products.

The guidance builds on practices developed during the COVID-19 pandemic and supports the goals of the Prescription Drug User Fee Act (PDUFA VII) and Biosimilar User Fee Act (BsUFA III) reauthorizations. It allows the FDA to rely on “alternative tools” such as virtual assessments, livestreaming of operations, or the review of facility records, along with inspection reports from trusted foreign regulators. These approaches are intended to make the agency’s oversight process more efficient without compromising safety or quality.

FDA emphasized that decisions to use remote or alternative tools will be made on a case-by-case basis, depending on factors such as a facility’s inspection history, the nature of its operations, and the risk profile of the products being evaluated. In addition, the guidance clarifies that facilities cannot request the use of these tools—the agency alone determines when they are appropriate.

For drug and biologic manufacturers, this new approach could shorten review timelines and reduce the need for travel-based inspections. However, companies must still maintain inspection-ready operations and be prepared to provide documentation or participate in remote reviews when requested.

Overall, the guidance highlights the FDA’s continued shift toward digital and virtual oversight methods, reflecting an effort to modernize its inspection process while ensuring timely access to safe and effective medicines. To read the full guidance, click here.