Public Comment
Comments provided on: February 24, 2025
Comments provided to: U.S. Food and Drug Administration; FDA-2024-D-2402
Description: The MRCT Center’s public comments on the FDA’s draft guidance, Considerations for Including Tissue Biopsies in Clinical Trials, recommend enhanced clarification on biopsy justification, prioritization of less invasive methods, consent specificity for future research, and strengthened IRB considerations to improve ethical rigor and participant protections.