Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry | FDA

Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry | FDA







FDA Issues Draft Guidance on Clinical Research with Cannabis and Cannabis-Derived Compounds

Today, the U.S. Food and Drug Administration issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry.” This draft guidance provides FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds.

With this draft guidance, FDA intends to respond to questions raised by stakeholders, including some raised during a public hearing held last year. The draft guidance covers topics such as sources of cannabis, information on quality considerations and background on calculating percent delta-9-tetrahydrocannabinol (THC) to provide clarity in response to a recent legislative change related to hemp. Finally, the draft guidance introduces key FDA regulatory concepts to stakeholders who may be less familiar with FDA, or our authorities, than other drug developers.

It is critical that FDA continues to do what we can to support the science needed to develop new drugs from cannabis. FDA believes the drug approval process represents the best way to ensure that safe and effective 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, such as this one.

FDA welcomes comments on this draft guidance. Please visit www.regulations.gov and enter docket number FDA-2020-D-1079 to submit comments.