https://www.fda.gov/media/84417/download
SOPP 8405.1Assay validation data & other minor clarifying information (determined by CBER as fitting the Class 1 category) such as a response to the CR letter that included only compliance issues are both Class 1 Resubmission.
Here's hoping that we get a 2-month review period for paediatric + some more updates in the coming days re: FDA alignment on the trial design for adult gvhd.
https://www.fda.gov/media/84417/downloadSOPP 8405.1Assay...
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