Get the Lowdown on FDA’s New Cannabis Research Guidance

Posted by Brian Sparks|July 24, 2020

The FDA has issued new proposed guidelines for clinical research into cannabis and cannabis-derived compounds. The guidelines outline the FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds, with a specific focus on quality considerations.

The draft guidance covers sources of cannabis for clinical research, information on quality considerations, and recommendations regarding calculating tetrahydrocannabinol levels.

The body of work also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities.

Ever since the passage of the 2018 Farm Bill, CBD has existed in a sort of regulatory limbo, according to an article written by Ciara Linnane on MarketWatch.com. While the bill legalized hemp, it did not legalize CBD, but rather moved enforcement of the substance away from the DEA and over to the FDA.

Learn more about FDA’s approach here.