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