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Slides

ABOUT

This webinar encourages the use of Drug Master Files (DMFs) and highlights quality considerations that have been issued recently in guidance to further support cannabis research. Cannabis related firms will learn how DMFs might be able to help address their concerns related to the disclosure of potentially proprietary information.

INTENDED AUDIENCE

• Drug developers and researchers working in the cannabis space.
• Growers of cannabis products used by drug developers and researchers who submit applications to FDA.

Topics Covered

• DMFs in cannabis research
• Quality guidance in cannabis research
• FDA’s role in regulation of cannabis products
• Cannabis drug development
• Botanical raw materials

FDA SPEAKER

Cassandra Taylor, Ph.D.
Chemist, Botanical Review Team (BRT)
Office of Pharmaceutical Quality (OPQ) | CDER | FDA

FDA RESOURCES

• DMFs: Drug Master Files (DMFs)
• Drug Master Files Guidance for Industry
• Guidance: “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry”