A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
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