When determining whether a lawfully marketed drug is IND exempt, is the IRB to evaluate only the current study, or any potential uses by the sponsor in the future? 1.22K viewsOctober 10, 2022FDA 0 Sam Smith11.38K October 20, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted October 20, 2020 0 Comments Spread the loveThe IRB can only consider the study that is in front of them. The IRB cannot consider or anticipate what a sponsor may or may not do in the future. Spread the love Login
