PDUFA
This article was originally published in The Tan Sheet
Executive Summary
Authority to waive or reduce prescription drug user fees redelegated to the director and associate director for policy at CDER. A final rule published Nov. 3 revokes authority previously delegated to the Chief Mediator and Ombudsman/User Fee Waiver Officer, the Deputy Chief Mediator and Ombudsman, and the Deputy User Fee Waiver Officer, except for reconsideration requests of user fee decisions made prior to July 1