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In addition to the IND and CDER processes, the FDA also issued a draft in July 2020. This is called: Cannabis and Cannabis Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry. This pertains to individuals considering conducting clinical research in this area.
In order to conduct clinical research on Cannabis related products scheduled by the DEA, interactions with several federal agencies are often needed. Registration by the DEA and obtaining the Cannabis for research by NIDA, National Institutes on Drug Abuse, within the National Institutes of Health, is required. Another DEA source could also register the Cannabis for study purposes, and there is a review by the FDA for the IND or INAD application. In addition, for a Schedule 1 controlled substance under the CSA, the DEA provides researchers with investigational protocols. It also has security level requirements at the testing site for the Cannabis sample.
NIDA provides research level Cannabis to be scientifically studied. This agency has the responsibility of overseeing the Cannabis growth for medical research purposes, and is contracted by certain universities to grow the Cannabis at a secure facility. Cannabis that consists of various potencies and composition is available. In addition, the DEA may allow more growers to produce Cannabis for research study.
Researchers work with the FDA and submit an IND application to a division of the Office of New Drugs, depending on its intended therapeutic use. Based on the results of studies at the IND stage, sponsors may also submit an application for marketing the drug after formal drug approval.
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