FDA to withdraw Omnitrope appeal notice

FDA and the Department of Justice will not appeal a U.S. district court's April ruling that said federal law requires FDA either to act on an NDA within 180 days of submission, or to secure agreement from the NDA's sponsor for a more protracted review. FDA spokesperson Kathleen Quinn told BioCentury that on June 9, the government had not decided whether it would appeal the decision and, facing a deadline, it filed a notice to preserve the option to appeal. The government has since decided not to exercise this option and therefore plans to file a notice of dismissal of the appeal, she said. ...