FDA leadership signaled further deregulatory initiatives while CDER Director George Tidmarsh outlined agency efforts to reassess surrogate endpoints and expand biomarker use for accelerated approvals. Commissioner Marty Makary indicated upcoming regulatory changes following recent moves to relax biosimilar trial requirements, and Tidmarsh described an initiative to evaluate surrogate endpoints for cancer and other diseases. The twin announcements suggest the agency is prioritizing both streamlined development pathways and greater reliance on validated biomarkers to accelerate approvals.