ICR Documents

Supporting Statement A Document Date Uploaded 0308 Biologics AER including combo products SSA 2024 Reduced.docx 09/10/2024 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded 83-C to add AERs for Combo Products as Biologic 83-C for 0308 to add Combo Product AER disclosure MARCH 2023.docx Justification for No Material/Nonsubstantive Change 03/20/2023 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received