FDA issues final guidance “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry.”

FDA issued the final guidance “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry.” This 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.

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FDA considered comments received on the draft guidance, issued in July 2020, as the agency worked to finalize the guidance. 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. 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. The agency is committed to supporting the development of these new drugs through the investigational new drug and drug approval processes and one key part of this process involves development of guidance, including this final guidance. The agency also continues to conduct research on various cannabis quality considerations, including recent research on quality standards in state programs permitting cannabis for medical uses and investigation of microorganisms in cannabis after heating in a commercial vaporizer.

Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry Docket Number: FDA-2020-D-1079 Issued by: Center for Drug Evaluation and Research This guidance outlines FDA’s current thinking on several topics relevant to clinical research related to the development of human drugs containing cannabis or cannabis-derived compounds. As defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), drug includes any product that is intended to diagnose, cure, mitigate, prevent, or treat a disease, or any product (other than food) intended to affect the structure or any function of the body. In general, this means any product (including one that contains cannabis or cannabis-derived compounds) marketed with a claim of therapeutic benefit, or with any other disease-related claim, is considered a drug. To be legally marketed in interstate commerce, drugs that are not biological products generally must either (1) receive premarket approval by FDA through the new drug application (NDA) or abbreviated new drug application (ANDA) process, or (2) for certain over-the-counter nonprescription drugs, meet the requirements in the FD&C Act for marketing without an approved NDA or ANDA. The recommendations in this guidance are intended for products that meet the legal definition of a drug under the FD&C Act.

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