Advocates for the agency worry that while each of the performance assessments seems reasonable individually, together the reports could burden staff to the point of pulling some from application reviews or other tasks to help complete them.

FDA inspected more foreign drug establishments in fiscal 2007 than in each of the five previous years, but visited less than 11 percent of such facilities, the Government Accountability Office estimates in a report released Oct. 22

Phase III study in newly diagnosed patients with NPM1-mutated AML could enable Kronos’ SYK-inhibitor to reach market two years earlier under accelerated approval than it would under a traditional endpoint, company says.