FDA issues Draft Guidance on Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research

On July 22, 2020, The Food and Drug Administration (FDA) issued a guidance that outlines FDA’s current thinking on several topics relevant to the development of cannabis and cannabis-derived products: The source of cannabis and cannabis-derived compounds for clinical research; general quality considerations for developing drugs that contain cannabis and cannabis-derived compounds; and calculation of percent delta-9 tetrahydrocannabinol (THC) in botanical raw materials, extracts, and finished products.

The FDA web page “FDA and Cannabis: Research and Drug Approval Process” provides the basic roadmap for conducting clinical research at FDA using cannabis and cannabis-derived compounds. The resources on this page may be helpful to those interested in better understanding FDA processes for conducting clinical trials using cannabis and cannabis-derived compounds.  FDA’s support of drug development extends to drugs containing cannabidiol and other compounds found in cannabis. One important element is encouraging drug developers to meet with FDA early in their development programs—ideally, before submitting an investigational new drug (IND) application. The pre-IND meeting is an opportunity to obtain FDA input on research plans and required content for an IND submission. The pre-IND meeting can be valuable in planning a drug development program, especially if sponsors’ questions are not fully answered by guidances and other information provided by FDA.

FDA’s Center for Drug Evaluation and Research (CDER’s) Small Business and Industry Assistance helps small pharmaceutical businesses and industry navigate the wealth of information that FDA offers, and assists in understanding the regulation of human drug products.

• See the guidance and file comments here.
• Comment deadline is September 21, 2020.
• Advocacy Contact: Linwood Rayford