The approval of new imaging agents has slowed, much as for therapeutic drugs. Schering
and Amersham, for instance, each spent about $150 million a year for the period 1999–2004 …

Radioactive imaging agents, like diagnostic drugs generally, undergo a drug development
process that parallels that of therapeutic agents, with similar development times but …

The outcomes of a 2011 Medical Imaging & Technology Alliance (MITA) conference helped
shape considerations about what might be the most appropriate pathways for the regulatory …

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) …

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 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 …

Dear Sir, Nuclear medicine techniques are in the forefront of molecular imaging, thereby
translating discoveries in molecular biology, genetics, pharmacology and many other …

The objective of this study was to estimate the financial cost of developing new imaging
agents for clinical use and to discuss the effects of these costs on the future clinical imaging …

Nuclear Medicine is the specialty of medical imaging, which utilizes a variety of
radionuclides incorporated into specific compounds for diagnostic imaging and therapeutic …

PET and PET/CT have revolutionized the diagnosis, staging, and monitoring of treatment
effect or recurrence for a wide range of cancers and shown promise for improving health …