GAO: FDA Is Meeting Performance Goals, But Review Times Are Extending

While the FDA generally met its performance goals for both priority and standard NDAs and BLAs between fiscal 2000 and 2010, the amount of time it took the agency to review those applications has slightly increased, according to a Government Accountability Office (GAO) report. Fiscal 2008 was the only year in this time frame that the FDA did not meet its goals. The FDA and drug industry stakeholders interviewed by GAO attributed these delays to the agency implementing risk evaluation and mitigation strategy requirements introduced as part of the FDA Amendments Act (FDAAA) of 2007.
Drug Industry Daily