Med News Today

Human Tissue Under Study

The Food and Drug Administration has finally decided to take a look at the human tissue industry.

The Food and Drug Administration (FDA) today announced the formation of a multidisciplinary FDA task force on human cell and tissue safety. The FDA Human Tissue Task Force (HTTF), which will be led by senior FDA officials from within the Center for Biologics Evaluation and Research (CBER) and the Office of Regulatory Affairs (ORA), 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 HTTF will be to assess the effectiveness of the implementation of the new tissue regulations, which went into effect in 2005. Of particular interest will be a review of recently reported findings that some tissue recovery establishments are not following federal requirements for tissue recovery.

“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,” said Jesse Goodman, MD, MPH, director of CBER. “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.”

Wonder what took them so long.

posted by nattietodd @ 7:33 AM