www.fdanews.com/articles/146860-most-fda-reviewers-not-required-to-meet-pdufa-goals-gao-finds
Most FDA Reviewers Not Required to Meet PDUFA Goals, GAO Finds
June 1, 2012
Meeting specific review goals for drugs and biologics is generally not a criterion in FDA reviewers’ performance plans, according to a Government Accountability Office (GAO) report requested by Congress. FDA reviewers are told to meet general timeliness expectations; however, a separate GAO report just found agency review times are increasing even though it meets most of its Prescription Drug User Fee Act (PDUFA) action goals.
Washington Drug Letter
Washington Drug Letter