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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2019-D-0849.