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GUIDANCE DOCUMENT

Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Guidance for Industry May 2019

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-0849
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to provide general framework recommendations to sponsors  developing stimulant drugs for treatment of attention deficit hyperactivity disorder (ADHD) in  pediatric and adult patients. This guidance does not address development programs for 1nonstimulant drugs.

 ADHD is a common neurobehavioral disorder with onset in childhood. It is characterized by a  pattern of developmentally inappropriate and maladaptive inattentiveness, impulsivity, and  hyperactivity, resulting in impairment in family, social, academic, and occupational functioning.  Stimulant drugs (e.g., methylphenidate, amphetamine) are the most commonly prescribed  medications for treatment of ADHD.

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All written comments should be identified with this document's docket number: FDA-2019-D-0849.

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