FDA and Cannabis Research

The FDA is responsible for the review and approval of any product used as a medication or therapeutic agent, including any products from plants such as cannabis. Researchers need to collaborate with the FDA and submit an IND application to the Center for Drug Evaluation and also Research (CDER).

The IND application procedure offers scientists a path to follow that consists of regular communications with the FDA to support effective medication advancement while safeguarding the clients who are enlisted in the trials.

Performing medical research study using cannabis-related substances that are arranged by the DEA frequently involves communications with several federal agencies. This includes: a registration administered by the DEA; acquiring the marijuana for research study from NIDA, within the National Institutes of Health, or an additional DEA-registered source; as well as evaluation by the FDA of the IND or INAD application as well as study method.

For a Schedule I regulated compound under the CSA, DEA required added security and protocols including Schedule I-level security requirements at the site marijuana will be examined. Clean and pure supplies of cannabis to test with are critical and therefore the FDA has partnered with the University of Mississippi to cultivate marijuana for study at a safe and secure center. In time the FDA may expand it’s program to include additional growers and distributors for clinical studies and research purposes.

FDA and Cannabis: Research and Drug Approval Process

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