GAO Gives FDA Drug Review Performance Seal Of Approval
FDA met most user fee performance goals for NDAs and BLAs received in fiscal years 2000 through 2010, the government watchdog agency says in a report prepared for Sens. Burr and Coburn. The legislators proposed legislation April 16 that includes a requirement for the agency to report annually on its adherence to the user fee goals.
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FDA Performance Assessments Include Drug Review Clock Sometimes, GAO Says
Government Accountability Office report finds that meeting PDUFA review goals is not an explicit element in CDER non-executive level employees’ performance plans. However, CDER Director Janet Woodcock’s performance plan includes an express reference to PDUFA performance goals, reflecting a “buck stops here” level of accountability.
User Fee Legislation Revs Through Senate Mark-up, But House Bill Goes Back Into The Shop
Senate health committee defers action on several potentially contentious issues, with members hoping to resolve differences over FDA’s authorities on imports, shortages, foreign data and track-and-trace before the bill goes to the floor, possibly in May. Meanwhile, the House postpones its mark-up in an effort to craft a more bipartisan bill, and now will try to push the user fee package to the floor during an upcoming four-day marathon session.
Innovation Pays: Priority Drugs Drove Novel 2011 Approvals To New Heights
The new molecular entity and novel biologic class of 2011 isn’t just the largest since 2004 – CDER also posted near-perfect on-time review performance while maintaining healthy rates of first-cycle approvals and a low 15 month average time to approval, thanks to a high level of innovation in the novel product candidates.