FDA Attention Deficit Hyperactivity Disorder Developing Stimulant Drugs for Treatment
标准简介
Attention Deficit Hyperactivity Disorder Developing Stimulant Drugs for Treatment[附网盘链接]由FDA于之前发布，适用于美国。标准截图
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标准文档类型为Attention Deficit Hyperactivity Disorder Developing Stimulant Drugs for Treatment[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Draft — Not for Implementation 1 Attention Deficit Hyperactivity Disorder: 2 Developing Stimulant Drugs for Treatment 1
3 Guidance for Industry 4 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 9 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 11 for this guidance as listed on the title page. 12 13 14 15 I. INTRODUCTION AND BACKGROUND 16 17 This guidance is intended to provide general framework recommendations to sponsors 18 developing stimulant drugs for treatment of attention deficit hyperactivity disorder (ADHD) in 19 pediatric and adult patients. This guidance does not address development programs for 20 nonstimulant drugs. 21 22 ADHD is a common neurobehavioral disorder with onset in childhood. It is characterized by a 23 pattern of developmentally inappropriate and maladaptive inattentiveness, impulsivity, and 24 hyperactivity, resulting in impairment in family, social, academic, and occupational functioning. 25 Stimulant drugs (e.g., methylphenidate, amphetamine) are the most commonly prescribed 26 medications for treatment of ADHD. 27 28 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 29 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 30 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 31 the word should in Agency guidances means that something is suggested or recommended, but 32 not required. 33 34 II. GENERAL CONSIDERATIONS 35 36 The principles outlined below apply to drug development programs for methylphenidate and 37 amphetamine products developed and submitted under the 505(b)(2) application pathway 38 (hereafter referred to as 505(b)(2) products) (section 505(b)(2) of the Federal Food, Drug, and 39 Cosmetic Act (FD&C Act)) as well as for novel (i.e., new molecular entity (NME)) stimulant 40 drugs. 41 1
This guidance has been prepared by the Division of Psychiatry Products in the Center for Drug Evaluation and Research at the Food and Drug Administration.
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