U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

All TitlesTitle 21Chapter IPart 312Subpart B - Subpart B—Investigational New Drug Application (IND)
§ 312.20 - Requirement for an IND.
§ 312.21 - Phases of an investigation.
§ 312.22 - General principles of the IND submission.
§ 312.23 - IND content and format.
§ 312.30 - Protocol amendments.
§ 312.31 - Information amendments.
§ 312.32 - IND safety reporting.
§ 312.33 - Annual reports.
§ 312.38 - Withdrawal of an IND.
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