George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research (CDER), announced the agency’s intent to closely reevaluate the use of surrogate endpoints employed to accelerate drug approvals. This development signals a potential shift in regulatory standards that could impact drug development timelines and evidentiary requirements, particularly for therapies previously expedited based on indirect measures of clinical benefit. The reassessment reflects ongoing efforts to balance rapid access with robust efficacy verification in the pharmaceutical landscape.