Regulations.gov document: Reference 11 - FDA, ICH guidance for industry ‘‘E6(R3) Good Clinical Practice,’’ (September 2025), available at https://www.fda.gov/media/169090/download (accessed Apr. 24, 2026). — retained record — High Signal
Regulations.gov document: Reference 11 - FDA, ICH guidance for industry ‘‘E6(R3) Good Clinical Practice,’’ (September 2025), available at https://www.fda.gov/media/169090/download (accessed Apr. 24, 2026).