Fed Regist. 1998 Oct 14;63(198):55067-9.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Developing Medical Imaging Drugs and Biologics." This draft guidance is intended to assist developers of drug and biological products used for medical imaging, as well as radiopharmaceutical drugs used in disease diagnosis, in planning and coordinating the clinical investigations of, and submitting various types of applications for, such products. The draft guidance also provides information on how the agency will interpret and apply provisions in the proposed regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring, which published in the Federal Register of May 22, 1998 (63 FR 28301).
美国食品药品监督管理局（FDA）宣布提供一份题为《医学成像药物和生物制品的开发》的行业指南草案。本指南草案旨在协助用于医学成像的药物和生物制品开发者，以及用于疾病诊断的放射性药物开发者，规划和协调此类产品的临床研究，并提交各类申请。该指南草案还提供了有关该机构将如何解释和应用1998年5月22日发布在《联邦公报》（63 FR 28301）上的用于诊断和监测的体内放射性药物拟议法规条款的信息。
