The purpose of this article is to reconsider the manner in which the US Food and Drug
Administration (FDA) reviews diagnostic radiopharmaceuticals. Mass characteristics of …

This article provides readers with some background on concerns raised by Dr. Marcus about
the evaluation of radiopharmaceuticals in this issue of The Journal of Nuclear Medicine (1) …

I. INTRODUCTION †œGeneralConsiderations for the Clinical Evaluation of Drugs―
should be reviewed before reading this guideline. It contains suggestions that are applicable …

Abstract Since 1975, the Food and Drug Administration has been primarily responsible for
the regulation of all radiopharmaceuticals. The process of new drug approval for …

In March 2004, the Food and Drug Administration (FDA) published a report entitled
Challenge and Opportunity on the Critical Path to New Medical Products in which it …

The regulatory policy of the Food and Drug Administration (FDA) on radiopharmaceuticals
flows from a rigid, traditional, drug-like interpretation of the FDC Act on the licensing of …

Objective: Pharmacologic interventions play an important role in nuclear medicine by
providing additional information which may help diagnose diseases, evaluate functional …

A joint Task Group of ICRP Committees 2 (Doses from Radiation Exposures) and 3
(Protection in Medicine; lead Committee for this report) has prepared a compilation of data …

To celebrate the 50th anniversary of the founding of the SNMMI Technologist Section in
1970, the Radiopharmaceutical Sciences Council board of directors is pleased to contribute …

The safety and efficacy expectations for US Food and Drug Administration (FDA) approval of
diagnostic radiopharmaceuticals (DRs) are described in laws that broadly apply to all …