Issue Date: January 18, 2017
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Assessment of Abuse Potential of Drugs
This guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their new drug product has abuse potential. This guidance also provides recommendations to applicants who intend to submit new drug applications (NDAs) for prescription drug products that may have abuse potential.
Download the Guidance Document
