FDA: Cannabis and Cannabis-Derived Compounds, Quality Considerations for Clinical Research, Draft Guidance for Industry

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1079]
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.” This draft guidance outlines FDA’s current thinking on several topics relevant to the development of cannabis and cannabis-derived products: the source of cannabis and cannabis-derived compounds for clinical research; general
quality considerations for developing drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, extracts, and finished products. This draft guidance has been developed to help support
clinical research into development of cannabis and cannabis-derived products.
Dated 7/16/2020.

Submit either electronic or written comments on the draft guidance by September 20, 2020 so that the Agency considers your comment on this draft guidance before it begins work on the final version of this guidance.

Click here to download for free: Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry.

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