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

Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.