Webcast | Virtual
Event Title
Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations
September 16, 2020
- Date:
- September 16, 2020
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”