How should the FDA review diagnostic radiopharmaceuticals?

Abstract

The purpose of this article is to reconsider the manner in which the U.S. Food and Drug Administration (FDA) reviews diagnostic radiopharmaceuticals. Mass characteristics of several common nonradioactive drugs and several diagnostic radiopharmaceuticals are considered. A history of the regulation of radiopharmaceuticals is presented. The Society of Nuclear Medicine and Molecular Imaging and the American College of Nuclear Medicine should choose the membership of a radiopharmaceutical advisory committee, and the FDA should contract with them to do so. Members of the radiopharmaceutical advisory committee should decide on the data to be presented by the manufacturer or the compounder and review those data, and the FDA should honor their decision. In this way, requirements would be radiopharmaceutical-specific, and much information of questionable usefulness would be foregone.