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FDA Releases Final Guidance For Cannabis Drug Development As Advocates Await Hemp And CBD Rules

Updated: Jan 30

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 marijuana.


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.

By Kyle Jaeger


OG Article: here.

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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 marijuana.


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 marijuana, which remains in Schedule I of the Contro