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The FDA plays a role in the investigation of Cannabis and its derivatives for medical use. In order to conduct clinical research which leads to the approval of a new drug, researchers must work with the FDA by submitting an IND application. IND stands for investigational new drug. This plan includes research on materials from plants such as Cannabis.
Researchers first submit an IND application to the Center for Drug Evaluation and Research, CDER. This process of the IND application enables researchers to follow a path that includes communication and interaction with the FDA on a regular basis. This means of communicating with their agency allows the FDA to support drug development and also protects the patients who are enrolled in the drug trials.
The Farm Bill of 2018 removed hemp from the Controlled Substances Act, or CSA. This change in the classification of hemp could help to refine the process for researchers to study Cannabis and its derivatives further, including CBD, which is classified under the definition of hemp. This could in turn advance the development of new drugs.
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