Discussion
FDA recommends that researchers interested in developing a cannabis-related drug should refer to the Botanical Drug Development Guidance for Industry and request a Pre-Investigational New Drug application meeting to discuss cannabis-specific issues. In addition, last week’s publication explains that those who are interested in cannabis-related drugs should contact the Center for Drug Evaluation and Research (CDER). Further, the FDA explains how potential researchers can actually get started on cannabis-related drug research by laying out two pre-study processes for cannabis-related drugs: a five-step process for cannabis study drugs containing hemp (with no more than 0.3% THC) and a seven-step process for cannabis study drugs controlled under the Controlled Substances Act (containing more than 0.3% THC). Internationally, ABDA prompts US FDA botanical drug guidance and collaborates with entities around the globe to develop traditional herbal medicines into botanical drugs in the US. Modern herbal medicines are in forms of pills or capsules. Their safety and efficacy have been demonstrated by daily use on large scale population. Identifying already-known effective herbal medicines with potential indication in the US is an efficient drug development pathway.
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