CONTEXT: A story of being in the right place at the right time for a SaaS
provider| FDA’s increasing interest and support for high-quality RWE in the
field of cannabinoid medicines plays to the strengths of Emyria. Small
but positive steps in the credibility given to RWD and RWE.
IMPACT: Low
READ TIME: 3 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