FDA Issues Draft Guidance to Encourage Cannabis-Related Clinical Research

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Cannabis-Related Clinical Research:

The following quote is attributed to FDA Principal Deputy Commissioner Amy Abernethy M.D., Ph.D.:

“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research. As that body of research progresses and grows, the FDA is working to support drug development in this area.

“It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis. The FDA believes the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs that contain cannabis or cannabis-derived compounds, are available to patients in need of appropriate medical therapy.

“The agency is committed to supporting the development of these new drugs through the investigational new drug, drug review and drug approval processes – and one key element of this support involves development of guidance, like this one.”

Additional Information:

Today, the U.S. Food and Drug Administration issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry” which describes the FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds.

The draft guidance covers sources of cannabis for clinical research, information on quality considerations and recommendations regarding calculating tetrahydrocannabinol (THC) levels.

The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities.

Additional Resources:

FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)

FDA and Cannabis: Research and Drug Approval Process

Botanical Drug Development: Guidance for Industry

Botanical Review Team (BRT)

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