How Should FDA Review Diagnostic Radiopharmaceuticals?

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 non-radioactive drugs and a number of diagnostic radiopharmaceuticals are considered. A history of the regulation of radiopharmaceuticals is presented. Conclusion: The Society of Nuclear Medicine and Molecular Imaging (SNMMI) and the American College of Nuclear Medicine (ACNM) should choose the membership of a Radiopharmaceutical Advisory Committee (RAC), and the FDA should contract with them to do so. Members of the RAC 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.

from # & – All via ola Kala on Inoreader http://ift.tt/2zjJpOy

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