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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Not for implementation.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This guidance is being distributed for comment purposes only.

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

Submit Comments by 07/03/2019

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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

Division of Dockets Management (HFA- 305)
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


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.