The U.S. Food and Drug Administration today issued the final guidance on clinical cannabis research. The “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry” guidance provides the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis and cannabis-derived compounds, according to a press release.
FDA considered comments received on the draft guidance, issued in July 2020, as the agency worked to finalize the suggested rules. Changes from the draft to the final guidance include clarifying sources of cannabis for clinical research (including Schedule I sources), adding resources explaining expectations for investigational new drug (IND) applications in various stages of drug development, and providing guidance on quality considerations for INDs.
The final guidance also:
- Lists applicable United States Pharmacopeia chapters on quality testing, including the assessment of leachables from packaging and delivery systems.
- Identifies relevant International Council for Harmonisation guidelines, FDA guidances, and considerations for devices used in combination with a drug.
- Addresses the calculation of delta-9 THC content, which is relevant to determine control status for cannabis and cannabis-derived compounds.
“It is critical FDA continues to support robust scientific research needed to develop new drugs from cannabis,” the release states. “FDA believes the drug development and approval process represents the best way to ensure that safe, effective, and high-quality new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.”
Earlier this month, The FDA said it is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements.