Drug Regulators, FDA- CDER, Publish Guidance on the Assessment of Abuse Potential of Drugs
Drug Regulators, FDA- CDER, Publish Guidance on the Assessment of Abuse Potential of Drugs.
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This guidance is intended to assist sponsors who are developing drug products with the potential for abuse that may need to be scheduled under the Controlled Substances Act (21 U.S.C. 811(b), 811(c)). Examples of products that are addressed in this guidance include new molecular entities and new dosage forms of drug substances already controlled under the Controlled Substances Act (21 U.S.C. 812(c)). 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.2
Specifically, the guidance discusses the following:
• The definition of abuse potential
• Information on submitting an abuse potential assessment, including a proposal for scheduling
• A description of what constitutes an adequate abuse potential assessment
• Information for sponsors performing an assessment, including (1) the design and conduct of appropriate studies and investigations and (2) general administrative recommendations for submitting a proposal for scheduling
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