FDA issues final guidance on cannabis and clinical research

Source: Cannabis Wire

Feb 2, 2023 | Policy and Regulation

“The U.S. Food and Drug Administration announced final guidance that “outlines FDA’s current thinking on several topics relevant to clinical research related to the development of human drugs containing cannabis or cannabis-derived compounds.”  Some of the most significant changes from the draft 2020 guidance come in the final section, in which FDA has made updates to how delta-9 THC content should be calculated for different product forms. Cannabis containing .3% THC or less is defined as hemp, which was removed from the Controlled Substances Act, or, in other words, made legal, through the 2018 Farm Bill, and thus is subject to different regulatory hoops.”  Read the article here.


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