ICR Documents

Supporting Statement A Document Date Uploaded 0014 INDs SSA AUG 2023 to add ICH Guidance REV.docx 08/08/2023 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded 0014 83-C to add Right to Try burden 0014 83C to add 0893 burden - Right To Try.docx Justification for No Material/Nonsubstantive Change 12/02/2025 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received