FDA’s Role in Regulation of Cannabis Products
Cassandra Taylor, Ph.D. (FDA)
The FDA plays an important role in the regulation of cannabis products. This presentation will focus on the development of cannabis and cannabis-derived compounds for use in human drug products. By nature, botanical drug development is complex and challenging for a variety of reasons. From FDA’s regulatory perspective, cannabis and cannabis-derived drug development is no different from the development of any other botanical drug. A high-level overview of the general Investigational New Drug (IND) application process will set the stage for further in-depth discussion on botanical drug development and more specifically on cannabis and cannabis-derived compounds used to develop human drugs. Additional insights on the recent draft guidance titled Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research will be presented. As well as highlighting the well established Drug Master File (DMF) pathway. DMFs are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMF information can be referenced in support of clinical trials or applications without divulging the confidential information within the DMF to the researcher or investigator.
Date and Location
Thurs Oct 15th, 2020
4:00 - 5:00 PM
Webinar link will be emailed to you upon registration
About the speaker
Cassandra Taylor, Ph.D. is a Chemist at U.S. Food and Drug Administration within the Center for Drug Evaluation and Research (CDER) and is a member of the Botanical Review Team (BRT) which resides within the Office of Pharmaceutical Quality (OPQ). BRT collectively serves as an expert resource for CDER on all botanical issues. Dr. Taylor received her B.S. in Chemistry with a minor in Forensics from St. Francis University in Loretto, PA (2005), and her Ph.D. in Analytical Chemistry from the University of Maryland in College Park, MD (2014) under the guidance of Dr. Alice Mignerey. Dr. Taylor joined FDA in December 2014 as a primary BRT reviewer and has evaluated over 100 botanical drug submissions from all CDER’s clinical divisions, with a focus on reviewing cannabis submissions. She serves as a cannabis subject matter expert (SME) for OPQ, CDER and across FDA, primarily concentrating on the botanical and quality aspects of cannabis. Dr. Taylor is the lead SME on the recently published draft FDA guidance for industry titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” She leads and coordinates the internal CDER Cannabis Working group and leads various cannabis initiatives within CDER. Dr. Taylor actively contributes as an SME to the internal FDA cross-agency cannabis groups, Marijuana Working Group and CBD Policy Working Group. She also works collaboratively with colleagues across the agency to help close the substantial knowledge gaps about the science, safety and quality of many of the cannabis products, including those containing cannabidiol. Dr. Taylor has presented at multiple forums internally and externally on the botanical drug review process and FDA’s role in the regulation of cannabis products.
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