FDA requests data on fetal tissue, cell trials

FDA is contacting trial sponsors, prospective sponsors, and researchers to remind them that the agency regulates the use of fetal cellular or tissue products in human clinical studies. FDA is requesting that researchers and sponsors contact the agency with information about on-going or planned trials involving fetal material.

In a Nov. 30 letter, Kathryn C. Zoon, Director of FDA's Center for Biologics Evaluation and Research, noted that "there has been confusion in the press and research community about federal oversight of these products." Zoon added, "because this is an evolving field with a number of issues to resolve, we request that you contact FDA to determine whether any clinical investigations you are conducting, planning or sponsoring would require submission of an Investigational New Drug (IND) application." FDA's letter may have been prompted by reports that some researchers using fetal cells experimentally in the course of medical treatment have not applied for INDs. ...