New staff puts PDUFA goals back on track, Jenkins says
Speaking at an Elsevier conference, Jenkins said he reversed a 2007 directive that allowed OND managers to miss PDUFA goals due to workload constraints caused by implementing the FDA Amendments Act (FDAAA) and the renewal of the user fee program. At the time, Jenkins instructed review managers that they may miss PDUFA deadlines by up to two months and decline some sponsor meeting requests, among other steps to manage workload and staff shortages.Over the past two years, the CDER has grown by 760 employees (34%) and the OND by 183 employees (26%). The downside, he said, is that 38% of the staff at the CDER and the OND have been on the job for less than two years. It's estimated that it can take over three years for a reviewer or project manager to be fully productive.