Zdrowie i gospodarka · 6.05.2019
Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical development of stimulant drugs for treatment of attention deficit hyperactivity disorder (ADHD) in pediatric and adult patients. Specifically, this draft guidance addresses the Agency's current recommendations regarding the development programs for methylphenidate and amphetamine products, as well as for novel (i.e., new molecular entity (NME)) stimulant drugs.