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.