Division of Medical Imaging Products, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, USA.
J Nucl Med. 2013 Aug;54(8):1479-84. doi: 10.2967/jnumed.112.117804. Epub 2013 Jun 7.
The safety and efficacy expectations for U.S. Food and Drug Administration (FDA) approval of diagnostic radiopharmaceuticals (DRs) are described in laws that broadly apply to all prescription drugs and biologic products. These laws also outline efficacy expectations that are unique for DRs. The FDA regulations and guidance documents elaborate on DR efficacy expectations for clinical uses of the drugs, such as the delineation of anatomy, the characterization of a physiologic process, or the diagnosis of disease. As described in the FDA regulations, the approval of a DR necessitates that the imaging drug has the ability to provide clinically useful information. Here we cite approved DRs to illustrate how the imaging performance of the drugs was characterized in clinical studies and the clinical usefulness of the imaging information described in drug labels.
美国食品和药物管理局 (FDA) 批准诊断放射性药物 (DR) 的安全性和疗效预期在广泛适用于所有处方药和生物制品的法律中有描述。这些法律还概述了 DR 特有的疗效预期。FDA 的法规和指导文件详细说明了 DR 对药物临床用途的疗效预期，例如解剖结构的描绘、生理过程的特征或疾病的诊断。如 FDA 法规所述，批准 DR 需要成像药物具有提供临床有用信息的能力。在这里，我们引用已批准的 DR 来说明药物在临床研究中的成像性能如何得到表征，以及药物标签中描述的成像信息的临床有用性。
