Medical Cannabis - FDA's Perspective on Research and Drug Development

In addition to the recently published FDA guideline on Quality Considerations for Clinical Research with Cannabis the FDA now published an article to assist researchers with developing cannabis-derived product (CCDP) clinical research programs.

In the article, the agency presents a breakdown of CCDP applications the FDA has received over the past 50 years, summarizes experiences and challenges in reviewing CCDP research applications, and provides recommendations and resources for those interested in studying CCDPs in human clinical trials. According to the agency, "this may include the use of newly identified or less common cannabinoids, as well as other components of the cannabis plant, such as terpenes".

FDA's Guidance Documents to Support Cannabis Drug Product Research

The FDA continues to support robust scientific research needed to develop new cannabis derived drugs and is committed to encouraging the research and development of these new drugs. Thus, the agency has published the following two guidance documents for industry:

• Botanical Drug Development. This 2016 guidance is intended to aid applicants in developing botanical drugs and provides the agency’s current thinking regarding growing conditions and quality controls for botanical raw materials.
• Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. This 2023 guidance reflects FDA’s current thinking on clinical research of human drugs containing CCDPs, with a focus on GMP compliant manufacturing of high-quality drugs.

For more information, please visit FDA's 50 Years of Experience with Cannabis Research Helping to Support Tomorrow's Cannabis Drug Development.