title: A regulatory perspective on the abuse potential evaluation of novel stimulant drugs in the United States.
abstract: In the United States of America (USA), the abuse potential assessment of a drug is performed as part of the safety evaluation of a drug under development, and to evaluate if the drug needs to be subject to controls that would minimize the abuse of the drug once on the market. The assessment of the abuse potential of new drugs consists of a scientific and medical evaluation of all data related to abuse of the drug. This paper describes the regulatory framework for evaluating the abuse potential of new drugs, in general, including novel stimulants. The role of the United States Food and Drug Administration (FDA) in the evaluation of the abuse potential of drugs, and its role in drug control are also discussed. A definition of abuse potential, an overview of the currently accepted approaches to evaluating the abuse potential of a drug, as well as a description of the criteria that applies when recommending a specific level of control (i.e., a Schedule) for a drug under the Controlled Substances Act (CSA). This article is part of the Special Issue entitled 'CNS Stimulants'.
authors.affiliation: Controlled Substance Staff, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA. Electronic address: silvia.calderon@fda.hhs.gov.
authors.forename: Silvia N
authors.initials: SN
authors.lastname: Calderon
authors.affiliation: Controlled Substance Staff, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Klein
mesh_terms: D000818:Animals; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000737:chemistry; D004341:Drug Evaluation / Q000331:legislation & jurisprudence* / Q000379:methods*; D004335:Drug and Narcotic Control / Q000379:methods*; D006801:Humans; D012646:Self Administration; D019966:Substance-Related Disorders / Q000517:prevention & control*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000697:Central Nervous System Stimulants
keywords: Abuse potential stimulants; Drug scheduling; Eight factor analysis