What's the Food and Drug Administration's impact on the cannabis industry?
With consumer safety and public health at its absolute core, the Council for Federal Cannabis Regulation (CFCR) will use its upcoming May webinar to focus on the findings in a recent FDA report designed to ensure that regulations presently in place for approved drug products in the marketplace are consistent with regulations applicable to cannabis products for medical use.
Follow The Science
Scheduled for Thursday, May 26, from 1:00 until 2:00 p.m. Eastern Time, the webinar will feature FDA scientists Schuyler Pruyn and Dr. Cassandra Taylor. The program will be moderated by CFCR’s Executive Director Sarah A. Chase along with Council Advisory Board Member Jack Jacobson, a cannabis, energy and education practices advisor for Thompson Coburn LLC.
The discussion is designed to shed specific light on the nature of Current Good Manufacturing Practices – also known as CGMPs, which regulate information available on public state-run websites and other sources that document the minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packaging of a drug product to assure it is safe for use. The crux of the conversation will focus on the fact that these same standards should be applicable to medical cannabis products presently in development that may be sold in the United States and will amplify the study and the need for standardized testing protocols and methodologies to ensure consumer safety.
“CFCR is committed to working with the FDA to help better inform this industry,” Chase said. “Communication matters and this is an important webinar because of the focus on quality and standards, which will ultimately inform federal regulation. Both CFCR and the FDA are focused on keeping consumer health and safety at the forefront of these conversations."
Speaker Profiles for the May 26 Webinar:
Schuyler Pruyn, M.S.
Schuyler Pruyn, M.S. earned her M.S. in pharmaceutical sciences from ACPHS in 2019 and her B.S. in chemistry from the University at Albany in 2017. She joined FDA and the Botanical Review Team (BRT) as a summer fellow in 2018 and returned full-time in July 2019. During her time with BRT, Schuyler worked closely with Dr. Cassandra Taylor, who is as a cannabis subject matter expert (SME). Schuyler trained under Dr. Taylor and assisted with various cannabis initiatives within CDER and across the Agency. In 2021, she spent 3 months working concurrently with BRT and the Intergovernmental Affairs Staff (IGA) in the Office of the Commissioner, and in 2022 she began working in the Office of Executive Programs (OEP) in CDER.
Cassandra Taylor, Ph.D.
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) residing within the Office of Pharmaceutical Quality (OPQ) and serves as an expert resource on all botanical issues. Dr. Taylor received her B.S. in Chemistry from St. Francis University (2005), and her Ph.D. in Analytical Chemistry from the University of Maryland (2014). Dr. Taylor has evaluated over 100 botanical drug submissions across CDER’s clinical divisions, with a focus on reviewing cannabis submissions. She serves as a cannabis subject matter expert (SME) for CDER and across FDA, concentrating on the botanical and quality aspects of cannabis. Dr. Taylor is the technical lead on the 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 many cannabis initiatives within CDER and FDA. Dr. Taylor is an active SME in the FDA cross-agency cannabis working group, Cannabis Products Committee (CPC). She collaborates with colleagues across FDA to help close substantial knowledge gaps about the science, safety, and quality of cannabis and cannabis-derived products.
To register for this CFCR’s webinar series, please visit: https://www.uscfcr.org/events
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