Abuse Liability and Drug Scheduling: The Role of the FDA Deborah B. Leiderman, M.D. Director, Controlled Substance Staff CDER/FDA

2/1/02


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Table of Contents

Abuse Liability and Drug Scheduling: The Role of the FDA Deborah B. Leiderman, M.D. Director, Controlled Substance Staff CDER/FDA

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NDA Requirements Under FD&C Act

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Drug Classes Subject to Regulation (CSA)

CSA Mandate for DHHS

Drug Scheduling Process

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Abuse Liability Assessment

Abuse Potential

Abuse Liability Assessment Package of the NDA Includes

Pharmacology - Preclinical

Human Pharmacology

Eight Factor Analysis (Required under CSA)

Scheduling Criteria CII-CV Drugs

FDA and DEA Roles Under CSA

CONCLUSIONS

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Author: Deborah Leiderman