FDA Releases Draft Guidance on Tissue Biopsies in Clinical Trials
January 07, 2025
January 07, 2025
WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued a draft guidance document titled "Considerations for Including Tissue Biopsies in Clinical Trials." This guidance is designed to aid industry professionals, clinical investigators, institutions, and institutional review boards (IRBs) in understanding best practices for conducting tissue biopsies in adults and children participating in clinical trials.