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

FDA Releases Final Guidance For Cannabis Drug Development As Advocates Await Hemp And CBD Rules
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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 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 development of cannabis and cannabis-derived human drugs.” FDA made several non-binding recommendations for researchers interested in developing cannabis drugs that could go to market. The advice is “intended to address the legal definitions and regulatory controls related to cannabis, and to address certain questions raised about drugs containing cannabis.” 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 The guidance has been revised since the draft version’s release. It adds clarity around federally authorized sources of cannabis for drug development purposes, for example. As a general rule, cannabis containing no more than 0.3 percent THC by dry weight meets the federal definition of hemp and is not considered a controlled substance…

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

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