Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry (JULY 2020)

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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.

The recommendations in this guidance are intended to provide clarity regarding a recent
legislative change (see section III) and to address certain questions raised in a recent public
hearing. The guidance also introduces key FDA regulatory concepts to stakeholders who may
be less familiar with FDA or our authorities than other drug developers.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.

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