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Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance outlines FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. Cannabis and cannabis-derived compounds that may be used in drug manufacturing include botanical raw materials, extracts, and highly purified substances of botanical origin. This guidance does not address development of fully synthetic versions of substances that occur in cannabis, sometimes known as cannabis-related compounds, which are regulated like other fully synthetic drugs. This guidance is limited to the development of human drugs and does not cover other FDA-regulated products.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1079.