Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3
Once sponsors decide to capture/share expanded access-derived data above and beyond that needed, what should IRBs do?

Once sponsors decide to capture/share expanded access-derived data above and beyond that needed, what should IRBs do?
In some cases there may be value in collecting “real world data” from Expanded Access.
Expanded access allows patients who lack other treatment options to try unapproved medical products in development.
Interesting empirical studies, policy analyses, and editorials on health law and policy issues from the month of August 2021.