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This guidance outlines FDA’s current thinking on several topics relevant to clinical research related to the development of human drugs containing cannabis or cannabis-derived compounds.

As defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), drug includes any product that is intended to diagnose, cure, mitigate, prevent, or treat a disease, or any product (other than food) intended to affect the structure or any function of the body. In general, this means any product (including one that contains cannabis or cannabis-derived compounds) marketed with a claim of therapeutic benefit, or with any other disease-related claim, is considered a drug.

To be legally marketed in interstate commerce, drugs that are not biological products generally must either (1) receive premarket approval by FDA through the new drug application (NDA) or abbreviated new drug application (ANDA) process, or (2) for certain over-the-counter nonprescription drugs, meet the requirements in the FD&C Act for marketing without an approved NDA or ANDA.

The recommendations in this guidance are intended for products that meet the legal definition of a drug under the FD&C Act.