FDA Releases Guidelines On Cannabis Research Following White House Review

FDA Releases Guidelines On Cannabis Research Following White House Review

The Food and Drug Administration (FDA) published draft guidance on developing cannabis-based drugs on Tuesday. This comes weeks after the White House completed its review of the document, clearing its path for public release. FDA is still in the process of developing regulations that could allow for CBD to be marketed as a food item or dietary supplement, but in the meantime it has worked to create these new research guidelines for drug manufacturing. Much of the guidance—which is “limited to the development of human drugs and does not cover other FDA-regulated products”—covers the basics of conducting federally authorized research for drug development purposes such as where researchers are allowed to obtain cannabis and the importance of demonstrating the ability to “consistently manufacture a quality product.” “A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research,” FDA Principal Deputy Commissioner Amy Abernethy said in a press release. “As that body of research progresses and grows, the FDA is working to support drug development in this area.” The chief legislative change she referenced is the 2018 Farm Bill, which federally legalized hemp and its derivatives such as CBD. For researchers, that reform means they are no longer bound to certain restrictions that exist for marijuana. For example, FDA noted in the new document that as long as a manufacturer produces hemp products that meet the federal definition of containing no…

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Source : MJ moment
Link to original : FDA Releases Guidelines On Cannabis Research Following White House Review
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