Today, the U.S. Food and Drug Administration issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry,” which describes the FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds.
The draft guidance covers sources of cannabis for clinical research, information on quality considerations and recommendations regarding calculating tetrahydrocannabinol (THC) levels. It also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities.
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