OIG to Continue Investigation of REMS Program in 2013

During the coming year, the HHS Office of Inspector General (OIG) will continue examining the risk evaluation and mitigation strategies (REMS) program and expects to release findings next year, the office says in its fiscal 2013 work plan. OIG will review drugmakers’ assessments of the program’s efficacy in minimizing risks and it will examine how well the FDA ensures manufacturer compliance.
Drug Industry Daily