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The FDA & real world evidence (RWE)

by Michelle
March 05, 2021
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"The FDA is uniquely situated to contribute its expertise in evaluating data from different sources to inform regulatory decision-making. We think that real-world data (RWD) on CBD use and safety has a crucial role alongside data from other types of studies to fill in the current gaps in our understanding."

Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner

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The crucial role of RWE

In this article by Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner, the limited understanding of the safety profile of CBD and many other cannabis-derived compounds, including potential safety risks for people and animals, is highlighted. They also identify an important public health opportunity: the use of 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.

"The FDA evaluates CBD just like any other substance we regulate, under a regulatory framework defined by law and with rigorous scientific evidence as a basis for both our regulatory approach and information we communicate. We’ve consistently communicated concerns and questions regarding the science, safety, and quality of many of these products based on currently available evidence. We still don’t have clear answers to important questions such as what adverse reactions may be associated with CBD products and what risks are associated with the long-term use of CBD products. Better data in these areas are needed for the FDA and other public health agencies to make informed, science-based decisions that impact public health."

In the article, the authors share a brief overview of their existing work on CBD and offer a framework for building a more robust evidentiary foundation to inform public health decisions.

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