Fed Regist. 1998 May 22;63(99):28301-9.
The Food and Drug Administration (FDA), in response to the requirements of the Food and Drug Administration Modernization Act of 1997 (FDAMA), is proposing to amend the drug and biologics regulations by adding provisions that would clarify the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis or monitoring of diseases. The proposed regulations would describe certain types of indications for which FDA may approve diagnostic radiopharmaceuticals. The proposed rule also would include criteria that the agency would use to evaluate the safety and effectiveness of a diagnostic radiopharmaceutical under the Federal Food, Drug, and Cosmetic Act (the act) and the Public Health Service Act (the PHS Act.
美国食品药品监督管理局（FDA）根据1997年《食品药品管理现代化法案》（FDAMA）的要求，提议修订药品和生物制品法规，增加相关条款，以明确用于疾病诊断或监测的体内放射性药物的评估和审批。拟议法规将描述FDA可能批准诊断用放射性药物的某些适应症类型。拟议规则还将包括该机构根据《联邦食品、药品和化妆品法案》（该法案）和《公共卫生服务法案》（PHS法案）评估诊断用放射性药物安全性和有效性时将使用的标准。
