FDA Unveils Plan To Fill CBD Research Gaps With ‘Real-World Data’ In 2021

MJ moment

The Food and Drug Administration (FDA) announced on Friday that it will be taking steps in the coming months to fill gaps in research about the safety and efficacy of CBD. Since hemp and its derivatives like cannabidiol were federally legalized under the 2018 Farm Bill, FDA has been developing regulations for products containing them. But the agency has been taking its time as it works to improve and expand data on the use and effects of CBD. In a new letter, FDA Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy noted the “rapid increase in the interest and availability” of the products but pointed out that “we still have a limited understanding of the safety profile of CBD and many other cannabis-derived compounds, including potential safety risks for people and animals.” In our latest #FDAVoices find out how we think real-world data on CBD use and safety has a crucial role and can be key in providing foundational science on CBD. https://t.co/MoQKKrqaPc — U.S. FDA (@US_FDA) January 8, 2021 “We see an important public health opportunity in using novel sources of data and rigorous analytical methods to build a more robust base of scientific evidence on the safety profile and use of CBD products,” they wrote. “The FDA is uniquely situated to contribute its expertise in evaluating data from different sources to inform regulatory decision-making.” To that end, the agency plans to enhance data collection in the new year. FDA described four primary challenges it has experienced in gathering that information, as well as seven research projects to “address current challenges in the collection and analysis of CBD-related data.” Those challenges include limited sources of information on adverse reactions to CBD products, a “poor” understanding of rates of cannabis use, a lack of “specific codes that can precisely…

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Source : FDA Unveils Plan To Fill CBD Research Gaps With ‘Real-World Data’ In 2021

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