Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Assessment of Abuse Potential of Drugs." This draft guidance is intended to assist sponsors who are developing drug and other medical products with the potential for abuse that may need to be scheduled under the Controlled Substances Act. Drugs with abuse potential generally include drugs that affect the central nervous system, drugs that are chemically or pharmacologically similar to other drugs with known abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change.