Drugs

FDA Framework for CBD Data Collection

FDA commissioner Stephen Hahn and principal deputy commissioner Amy Abernathy say the nation still has a limited understanding of the safety profile of cannabidiol (CBD) and many other cannabis-derived compounds, including potential safety risks for people and animals. “At FDA we see these knowledge gaps as an opportunity to develop new ways of building the science to inform public health decisions,” the two write in an online FDA Voices post.

The post gives background on FDA’s ongoing work on CBD and the work it has done with stakeholders on the issue. It also discusses the agency’s product sampling and testing activities.

Hahn and Abernathy write that filling the existing evidence gaps “will not be a trivial exercise but will require high-quality data analyzed using robust methods. We believe there is an opportunity to develop better sources of real-world data to provide incremental improvements in our scientific understanding of the safety profile of CBD in the general population and, potentially, in specific populations. We believe that ongoing efforts to systematically collect data on the safety and use of CBD are important and we are engaging with stakeholders to advance this work. At the same time, we see a critical opportunity for FDA to work collaboratively with partners in government, industry, and academia to develop the foundation for more robust CBD data collection and analysis projects.”

The post describes a framework for the agency’s work in the development of research projects that lay the methodological groundwork for high-quality real-world data science on the safety and use of CBD products. “These research projects would be aimed at building upon currently existing independent state and national quality and safety monitoring efforts, observational study data models, and novel data sources to develop more robust capabilities and methods for CBD data collection and analysis,” it says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome