ICR Documents

Supporting Statement A Document Date Uploaded 0338 BLAs Supporting Statement 2023 REV.docx 02/26/2023 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded Request for Changes to PDUFA Forms 0014 and 0338 PDUFA Forms Change Request Sept 2022.docx Justification for No Material/Nonsubstantive Change 09/01/2022 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received