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.