FDA introduces human tissue task force
This article was originally published in The Gray Sheet
Executive Summary
The group is charged to assess the effectiveness of new tissue regulations that took effect in May 2005, focusing on recent findings that some tissue recovery establishments do not follow federal requirements, the agency said Aug. 30 (1"The Gray Sheet" Nov. 22, 2004, p. 6). "The creation of this task force is part of the agency's overall plan to ensure that all human cells and tissues are as safe as possible," said Jesse Goodman, MD, director of the Center for Biologics Evaluation & Research. On Aug. 18, FDA ordered Donor Referral Services to cease manufacturing of human cells, tissues and cellular and tissue-based products and to retain all such products. An FDA inspection of the Raleigh, N.C., operation found "serious" violations of manufacturing procedures and recordkeeping requirements...