In Brief: Clinical holds
Executive Summary
Clinical holds: Center for Drug Evaluation & Research clinical hold review committee will meet in June to discuss confidentially, at a company's request, any trial placed on hold by CDER in the past 12 months. Companies should submit review requests by May 3 to Amanda Pedersen, FDA Chief Mediator and Ombudsman, Office of the Commissioner (HF-7), FDA, rm. 14-105, Rockville, Md. 20857...