ICR Documents

Supporting Statement A Document Date Uploaded SSA Individual Patient Expanded Access Applications REVISED CLEAN.doc 04/25/2016 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded Form FDA 3926 Rev 2017 FDA-3926_R2_v2_design (2).docx Supplementary Document 06/06/2017 Form FDA 3926 Instructions Rev 2017 FDA-3926_instr supp_R2_v3.docx Supplementary Document 06/06/2017 Non Substantive Change Request 0814 Change Request 13 July 2017 (2).pdf Justification for No Material/Nonsubstantive Change 07/17/2017 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received