FDA off-label promotion reform implementation task force to be headed by Office of Policy's Dotzel.
Executive Summary
FDA OFF-LABEL DISSEMINATION IMPLEMENTATION TASK FORCE IS CHARIED BY OFFICE OF POLICY Senior Policy Analyst Peggy Dotzel. The working group will be charged with developing regulations governing the dissemination of journal articles covering unapproved uses of drugs, biologics and devices. The off-label task force has one of the tighter deadlines under the FDA Modernization Act of 1997, with a regulation due by Nov. 21.