The FDA Human Tissue Task Force (HTTF) will be led by senior FDA officials from within the Center for Biologics Evaluation and Research and the Office of Regulatory Affairs.
It was established as part of the agency's efforts to strengthen its comprehensive, risk-based system for regulating human cells and tissue.
The main priority of the HTTF will be to assess the effectiveness of the implementation of new tissue regulations, which went into effect in 2005.
Of particular interest to the FDA will be reviewing recently reported findings that some tissue recovery establishments are not following federal requirements for tissue recovery.
Jesse Goodman, director of the Center for Biologics Evaluation and Research, says in a statement, "The primary goal of the new task force is to identify whether any additional steps are needed to further protect the public health while assuring the availability of safe products."
He adds, "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."
The FDA statement says the agency wants to explore what additional steps need to be taken to ensure firms follow required practices to prevent the transmission of communicable diseases.
Within the next three months, the task force will develop an action plan. It will also propose changes to existing policies, as well as generate a set of recommendations, identify what resources are needed to support these actions and report on how the agency can immediately implement its action plan.
