FDA Seeks Public Comment on Draft Guidance for Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry

August 14, 2020

The US Food and Drug Administrative (FDA) published official notice in the Federal Register,  https://www.federalregister.gov/documents/2020/07/22/2020-15907/cannabis-and-cannabis-derived-compounds-quality-considerations-for-clinical-research-draft-guidance seeking comments on 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.”

Comments can be submitted at any time, but the FDA is looking for comments by September 21, 2020, to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.

The draft guidance can be found here: https://www.fda.gov/media/140319/download




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