FDA Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders
标准简介
Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders[附网盘链接]是于之前发布的FDA标准，适用于US。标准截图
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标准文档类型为Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders[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
Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders 1
Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance provides recommendations for establishing clinical effectiveness for drugs intended to treat male hypogonadotropic hypogonadism associated with obesity and other conditions that do not cause structural disorders of the hypothalamus or pituitary gland. These drugs should both increase serum testosterone concentrations and improve how patients feel, function, or survive. This guidance incorporates advice the FDA received at a December 2014 2
advisory committee meeting on the appropriate indicated population for testosterone therapy 3
and a December 2016 advisory committee meeting on hypogonadotropic hypogonadism. This guidance does not address the development programs for testosterones or testosterone esters seeking the traditional indication of replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. This guidance also does not address the development of drugs to treat specific conditions associated with male hypogonadotropic hypogonadism (e.g., weight management in patients with obesity). 1
This guidance has been prepared by the Division of Bone, Reproductive and Urologic Products in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2
See the FDA’s archived 2014 Meeting Materials, Drug Safety and Risk Management Advisory Committee web page at https://wayback.archive-
it.org/7993/20170403223847/https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Drug
SafetyandRiskManagementAdvisoryCommittee/ucm380883.htm. 3
See Meeting Materials on the FDA’s December 6, 2016: Meeting of the Bone, Reproductive, and Urologic Drugs Advisory Committee web page at https://www.fda.gov/AdvisoryCommittees/Calendar/ucm522253.htm.
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