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US: FDA releases final guidance for cannabis drug development as advocates await hemp and CBD rules

The Food and Drug Administration (FDA) has released its finalized guidance on developing cannabis-based drugs, outlining the process and unique considerations for scientists when it comes to hemp and cannabis.

The guidance—titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”—was announced in a notice set to be published in the Federal Register on Tuesday. The agency previously released a draft version that went through a White House review in 2020.

Part of the reason for the guidance is the federal legalization of hemp in the 2018 Farm Bill, which makes the drug development protocol different for that version of the cannabis crop than it is for cannabis, which remains in Schedule I of the Controlled Substances Act (CSA).

“This guidance outlines FDA’s current thinking on several topics relevant to the development of cannabis and cannabis-derived human drugs, including the source of cannabis for clinical research,” FDA said. “This guidance is being issued to support clinical research for the development of cannabis and cannabis-derived human drugs.”


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