21 CFR Subpart 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.