I was kinda hoping aGVHD would fit into this 'exception' category during the shutdown being a life saving treatment @pfeifer1982 - but who knows ?
https://www.forbes.com/sites/joshua...ns-impact-on-fda-drug-approvals/#79925adb2d08
Consequently, the FDA has suspended reviews of existing Investigational New Drug (IND) and Biologics License Application (BLA) applications not covered by user fees, and is not
reviewing applications for new drugs and biologics submitted during the shutdown period, except for emergency INDs and BLAs.
Stem cells ramping up.., page-52
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