FDA Developing Medical Imaging Drug and Biological Products Part 3 Design, Analysis, and Interpretation of Clinical Studies
标准简介
Developing Medical Imaging Drug and Biological Products Part 3 Design, Analysis, and Interpretation of Clinical Studies[附网盘链接]是于不久前发布的FDA标准，适用于U.S。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 3 Design, Analysis, and Interpretation of Clinical Studies[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
1
2 Guidance for Industry
3 Developing Medical Imaging Drug and Biological Products
4 Part 3: Design, Analysis and Interpretation of Clinical Studies
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6
7
8
9 This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It
10 does not create or confer any rights for or on any person and does not operate to bind FDA or the public. 11 An alternative approach may be used if such approach satisfies the requirements of the applicable statutes
12 and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for
13 implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate
14 number listed on the title page of this guidance.
15
16
17
18
19 I. INTRODUCTION
20
21 This guidance is one of three guidances intended to assist developers of medical imaging drug
22 and biological products (medical imaging agents) in planning and coordinating their clinical
23 investigations and preparing and submitting investigational new drug applications (INDs), new
24 drug applications (NDAs), biologics license applications (BLAs), abbreviated NDAs (ANDAs),
25 and supplements to NDAs or BLAs. The three guidances are: Part 1: Conducting Safety
26 Assessments; Part 2: Clinical Indications; and Part 3: Design, Analysis, and Interpretation of
27 Clinical Studies.
28
29 Medical imaging agents generally are governed by the same regulations as other drug and
30 biological products. However, because medical imaging agents are used solely to diagnose and
31 monitor diseases or conditions as opposed to treat them, development programs for medical
32 imaging agents can be tailored to reflect these particular uses. Specifically, this guidance
33 discusses our recommendations on how to design a clinical development program for a medical
34 imaging agent including selecting subjects and acquiring, analyzing, and interpreting medical
35 imaging data. 36
37 FDA's guidance documents, including this guidance, do not establish legally enforceable
38 responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should
39 be viewed only as recommendations, unless specific regulatory or statutory requirements are
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.
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