FDA Scrutinizes Human Stem Cell Therapies

June 9, 2008

With several companies and dozens of academic researchers pushing to turn stem cells into therapeutics, officials at the US Food and Drug Administration (FDA) are striving to stay a step ahead. Yet judging from
an advisory meeting held in April, anticipating the regulatory challenges associated with cell therapies will entail a delicate balancing act. On the one hand, such cell therapies may offer new therapeutic avenues for intractable diseases and injuries; on the other, they pose difficult-to-appraise risks, such as cancer and immunogenicity. (Premium content from Nature Biotechnology)