The U.S. Food and Drug Administration (FDA) issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry” on Tuesday, August 27th, 2020. This is the first draft guidance from the FDA regarding the cannabis industry, and while nothing was stated startling to industry insiders, it does provide insight into FDA’s current thinking on clinical research in the course of the development of drugs containing cannabis or cannabis-derived compounds. The draft guidance covers topics such as sources of cannabis for clinical research, information on quality considerations, and recommendations regarding calculating delta-9 tetrahydrocannabinol (THC) levels. The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities.
Agustin Rodriguez, Cannabis Business Executive – Cannabis and Marijuana industry news, 08/25/2020 08:35:01