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GUIDANCE DOCUMENT

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

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
2019-09193
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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-09193.