Emergency use INDs and Single Patient INDs — they’re sorta the same, but not really. Each time we get one or the other in the IRB office, we scramble for the relevant FDA guidances for a refresher on their processing.
We finally wised up and created a summary table describing the two types of IND submissions intended for individual patients. While it’s primarily intended for IRB staff and reviewers, we thought it would be helpful to those requesting this type of IND for a patient. So it’s now posted on our website, way at the very bottom of the “Emergency Use” page.