FDA Developing Medical Imaging Drug and Biological Products Part 2 Clinical Indications
标准简介
Developing Medical Imaging Drug and Biological Products Part 2 Clinical Indications[附网盘链接]是于当前发布的FDA标准，适用于United States。标准截图
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标准文档说明
标准文档类型为Developing Medical Imaging Drug and Biological Products Part 2 Clinical Indications[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
1
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2 Guidance for Industry
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4 Developing Medical Imaging Drug and Biological Products 5 Part: 2 Clinical Indications
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10 This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It
11 does not create or confer any rights for or on any person and does not operate to bind FDA or the public. 12 An alternative approach may be used if such approach satisfies the requirements of the applicable statutes
13 and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for
14 implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate
15 number listed on the title page of this guidance.
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20 I. INTRODUCTION
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22 This guidance is one of three guidances intended to assist developers of medical imaging drug
23 and biological products (medical imaging agents) in planning and coordinating their clinical
24 investigations and preparing and submitting investigational new drug applications (INDs), new
25 drug applications (NDAs), biologics license applications (BLAs), abbreviated NDAs (ANDAs),
26 and supplements to NDAs or BLAs. The three guidances are: Part 1: Conducting Safety
27 Assessments; Part 2: Clinical Indications; and Part 3: Design, Analysis, and Interpretation of
28 Clinical Studies.
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30 Medical imaging agents generally are governed by the same regulations as other drugs or
31 biological products. However, because medical imaging agents are used solely to diagnose and
32 monitor diseases or conditions as opposed to treat them, development programs for medical
33 imaging agents can be tailored to reflect these particular uses. Specifically, this guidance
34 discusses our recommendations on selecting and studying clinical indications for medical
2
35 imaging agents administered in vivo. 1
This guidance has been prepared by the Division of Medical Imaging and Radiopharmaceutical Drug Products and
the Office of Therapeutics Research and Review in the Center for Drug Evaluation and Research (CDER) at the
Food and Drug Administration. 2
In response to the requirements of the Food and Drug Administration Modernization Act of 1997, FDA amended
the drug and biologics regulations (21 CFR 315 and 601) by adding provisions for the evaluation and approval of in
vivo radiopharmaceuticals used in the diagnosis or monitoring of diseases (64 FR 26657, May 17, 1999). This
guidance elaborates on the provisions contained in that regulation.
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