SAFETY EVALUATION OF BOTANICALS AS NEW DRUGS: A REPORT FROM CDER BOTANICAL TEAM

This presentation will summarize the experience of safety evaluation for botanical products to be used as drugs, from the perspective of U.S. Food and Drug Administration (FDA). The current regulatory environment will be reviewed first, with a report on the status of botanical drug applications in FDA’s Center for Drug Evaluation and Research (CDER). Regulatory experience and related issues in the safety reviews of botanical applications will then follow. More emphasis will be placed on the safety assessment of botanical INDs (Investigational New Drug application); basic principles in safety review of botanical NDAs (New Drug Application for marketing approval) will also be discussed.