NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

It’s a whole era for the FDA. RWE represents a fundamental shift toward a new paradigm. The FDA is rapidly evolving as new science and new technologies are emerging.

RWE is not only for oncology. The FDA is working to develop RWE standards for all drugs and medical devices needed in all areas of medicine.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug

https://www.fda.gov/drugs/news-events-human-drugs/fda-approval-demonstrates-role-real-world-evidence-regulatory-decision-making-drug-effectiveness

https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence