2023-01286: Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research." This guidance outlines FDA's current thinking on several topics relevant to the development of cannabis and cannabis-derived human drugs, including the source of cannabis for clinical research; general quality considerations for developing human drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, intermediates, drug substances, and drug products to determine their control status. This guidance is being issued to support clinical research for development of cannabis and cannabis-derived human drugs. This guidance finalizes the draft guidance of the same title issued on July 22, 2020.
The agency’s own summary, as published.
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