CONTEXT:  A company looking to explore new ways to expand the use of RWD in drug development.  By utilising the power of RWD to look at treatment models overall, it is easy to see why the FDA look favourably on this type of developing data.

IMPACT:  Medium

READ TIME:  2 mins



1. “( ) is encouraged by a recent perspective shared by the leadership of the US Food and Drug Administration (FDA) highlighting the potential role of real-world data (RWD) to improve the understanding of the safety and uses of cannabidiol (CBD).” 

2. “The data-backed drug development company believes the increasing interest and support for high-quality from the FDA, particularly in the field of cannabinoid medicines, bodes well for its strategy to use its proprietary data platform and unique RWE assets to inform and support multiple drug registration programs targeting unmet needs.” 

3. ““This recent FDA leadership perspective highlights the value the FDA places on high-quality RWD but also reinforces their strict standards for high-quality clinical evidence to support drug registration.” 

4. ““We are now using this data to launch our own drug development and registration programs targeting major unmet needs and intend to use our RWD and supporting trial data to seek registration with the TGA and then other global regulators, like the FDA.”” 

5. “In an article titled ‘Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products’, Dr Stephen Hahn, immediate past Commissioner of Food and Drugs and Dr Amy Abernethy, Principal Deputy Commissioner state: “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.”” 
Source URL: https://www.proactiveinvestors.com.au/companies/news/939555/emyria-encouraged-by-us-fdas-position-on-real-world-data-on-cbd-regulation-939555.html