Managing the Obstacles in the Path to Regulatory Approval of PET

Abstract

At a 1988 symposium at the University of California Lawrence Berkeley Laboratory on local and regional delivery systems for PET¹, Dr. John Palmer, then Director of the FDA Division of Medical Imaging, Surgical and Dental Products, was called to task during a question and answer period for FDA’s apparent lack of responsiveness in approving the radiopharmaceutical 2-¹⁸FDG for use in PET. He patiently explained that the FDA Center for Drug Evaluation and Research, of which his group is a part, does not seek out experimental products to evaluate. It reviews applications submitted to it by outside sponsors. He said that what he was trying to figure out was that if PET is so allfired important, why, in the twelve years or so FDG has been around, no one has submitted an NDA for it.