5/6 June 2024
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".
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:
For more information, please visit FDA's 50 Years of Experience with Cannabis Research Helping to Support Tomorrow's Cannabis Drug Development.