“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.”
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