FDA Assessment of Abuse Potential of Drugs

标准简介

标准截图

标准文档说明

标准部分原文

Assessment of Abuse Potential of Drugs 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION 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. Drug products with abuse potential generally contain drug substances that have central nervous system (CNS) activity and produce euphoria (or other changes in mood), hallucinations, and effects consistent with CNS depressants or stimulants. Thus, if a drug substance is CNS-active, the new drug product containing that drug substance will likely need to undergo a thorough assessment of its abuse potential and may be subject to control under the Controlled Substances Act (CSA) (see generally 21 U.S.C. 811). The CSA contains five schedules of control: Schedules I, II, III, IV and V. Drugs or other substances with a high abuse potential, no currently accepted medical use, and a lack of accepted safety for use under medical supervision are controlled in Schedule I. Drugs or other substances with abuse potential that do have a currently accepted medical use (e.g., the drug or substance is in an FDA-approved product) are placed into Schedule II, III, IV, or V. The specific placement of a drug or other substance within Schedules II-V is determined by the relative abuse potential of the drug or substance and the relative degree to which it induces psychological or physical dependence (21 U.S.C. 812(b)). In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 1

This guidance has been prepared by the Controlled Substance Staff (CSS) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration.

网盘链接

百度网盘：https://pan.baidu.com/s/1iWeyZMOgTaz0VVyFi1dU7w
提取码：vrnm