FDA Issues Draft Guidance To Encourage Cannabis Clinical Research

The U.S. Food and Drug Administration has issued a nine-page document to lead and encourage cannabis research.

The guideline expands on FDA’s position regarding clinical research linked to the development of new drugs containing cannabis or cannabis derivatives. This includes extracts, botanical raw materials, and highly purified substances and does not address the development of synthetic substitutes know as cannabis-related compounds.

Check out this list of FDA’s Cannabis-related Terms.

Background

A drug that hasn’t been clinically tested and is not generally deemed as safe and effective to prescribe is considered a “new drug” and must be approved by the FDA.

Trials may be conducted under an investigational new drug (IND) application to determine if …

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