]> 2026-10-07T12:23:06+02:00 Document:USA 21 CFR Part 312 09-Apr-2025 3000 en Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter D—Drugs for Human Use Part 312 Investigational New Drug Application https://www.ecfr.gov/current/title-21 EN 21 CFR Part 312 USA 21 CFR Part 312 09-Apr-2025 No HM Current Florian Adragna Legal act USA 09-Apr-2025 2026-07-16T12:46:53Z 2461238.0325579 USA 21 CFR Part 312 09-Apr-2025 3000 1 table 3 [[Reference:+]] [[HasDocument::Document:USA 21 CFR Part 312 09-Apr-2025]] USA 21 CFR Part 312 09-Apr-2025# QUERYe17d0ef52a13746d59167ca97c287581 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigation 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigation Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.21 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.21 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.85 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.85 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (d) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (d) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - IEC 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.3 - IEC Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (b) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.40 (b) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.62 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-001 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.57-001 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor-Investigator 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - Sponsor-Investigator Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - CRO 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.3 (b) - CRO Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.50 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.50 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.52 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.52 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.53 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Investigator 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Investigator Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-001 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.60-001 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64-001 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.64-001 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (viii) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.53 (viii) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.60-002 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.60-002 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (c) - (d) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (c) - (d) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.6 - §312.8 ; § 312.10 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.6 - §312.8 ; § 312.10 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.40 (c) (d) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.40 (c) (d) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (b) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.53 (b) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.61 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.61 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (a) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.62 (a) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.69 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.69 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.53 (c) (vi) - (vii) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.70 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.70 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (b) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.62 (b) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.53 (d) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.53 (d) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.30 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.31 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.31 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.58 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.58 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.68 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.68 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Adverse event Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (b) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.32 (b) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (c) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.32 (c) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (d) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.32 (d) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) - (b) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) - (b) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 (b) (ii) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.30 (b) (ii) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.44 (d) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.44 (d) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.56 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.56 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.38 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.38 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.42 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.42 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.44 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.44 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.45 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.45 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.57-002 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.57-002 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.62 (c) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.62 (c) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.33 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64-002 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.64-002 Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.64 (c) - (d) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.64 (c) - (d) Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) (3) 3002 en USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) (3) HasDocument 102 en HasDocument