Final Rule for GTP

The FDA's Center for Biologics Evaluation and Research (CBER), published the final Rule concerning Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product (GTP) Establishments; Inspection and Enforcement. A document for Roll-Out of GTP Final Rule was published at the same time. This is the last of three rules to be finalized as part of the Agency's overall plan to make human cells and tissues even safer. GTP includes the methods, facilities and controls. With this final rule, FDA's efforts to establish a new, comprehensive, and risk-based approach to this promising and innovative field of medicine can be realized. The new approach will be fully implemented on May 25, 2005.