Ensuring flexibility in inspection tools

The Secretary shall update inspection processes and existing tools to advance a risk-based approach to evaluate, including conducting inspections, of establishments engaged in the manufacture, preparation, propagation, or processing of biosimilar biological products to enable the Food and Drug Administration to— (1) increase utilization of remote regulatory assessments under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), in accordance with the guidance issued by the Food and Drug Administration, titled Conducting Remote Regulatory Assessments—Questions and Answers (June 24, 2025) (or any successor guidance); and (2) maximize the use of alternative tools set forth in the guidance described in paragraph (1) to improve inspection efficiency.