The Food and Drug Administration (FDA) issued final guidance, titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” outlining its stand on topics relevant to scientists related to the development of human medicinal products containing cannabis or cannabis-derived compounds.
What’s In The Guidance?
“This guidance addresses the legal definitions and regulatory controls related to cannabis, and it addresses certain questions raised in a public hearing about drugs containing cannabis and cannabis-derived compounds,” per the FDA website. It also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the agency or its authorities than other drug developers.
As Marijuana Moment first reported, the FDA guidance was announced in a notice set to be published in the Federal Register on Tuesday.
Today, FDA issued a final guidance which 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: https://t.co/wCsVRpi8J6 pic.twitter.com/F2UgQXY9uO
— FDA Drug Information (@FDA_Drug_Info) January 23, 2023
In addition, FDA provides …