ARTICLE | Politics & Policy
FDA finalizes guidance on cell and gene therapy trial design
June 13, 2015 12:38 AM UTC
FDA issued final (see BioCentury Extra, July 7, 2013).
The updated document outlines federal requirements for Institutional Review Board approval of pediatric trials. It now includes language noting that use of an invasive procedure in control groups of pediatric trials should not present more than minimal risk. ...