FDA Acute Myeloid Leukemia Developing Drugs and Biological Products for Treatment Draft
标准简介
Acute Myeloid Leukemia Developing Drugs and Biological Products for Treatment Draft[附网盘链接]是Food And Drug Administration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Acute Myeloid Leukemia Developing Drugs and Biological Products for Treatment Draft[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
Draft — Not for Implementation 1 Acute Myeloid Leukemia: Developing Drugs and Biological 2 Products for Treatment 1
3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 15 I. INTRODUCTION 16 17 The purpose of this guidance is to assist sponsors in the clinical development of drugs and 2
18 biological products for the treatment of acute myeloid leukemia (AML). Specifically, this 19 guidance addresses FDA’s current thinking regarding the overall development program and 20 clinical trial designs for the development of drugs to support an indication of treatment of 21 AML, including indications limited to an individual phase of treatment (e.g., maintenance, 3
22 transplantation preparative regimen, etc.). 23 24 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 25 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 26 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 27 the word should in Agency guidances means that something is suggested or recommended, but 28 not required. 29 30 31 II. BACKGROUND 32 33 AML is a malignant neoplasm arising from a myeloid-lineage progenitor. Although the disease 34 is clonal, the molecular pathogenesis is highly heterogeneous. The International Agency for 35 Research on Cancer classifies AML and related neoplasms on the basis of morphological, 1
This guidance has been prepared by the Oncology Center of Excellence, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research in consultation with the Center for Devices and Radiological Health at the Food and Drug Administration. 2
For the purposes of this guidance, references to drugs include drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355) and biological products licensed under section 351 of the Public Health Service Act (42 U.S.C. 262). 3
In addition to consulting guidances, sponsors are encouraged to contact the appropriate review division to discuss specific issues that arise during the development of drugs for the treatment of AML.
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