Subpart B—Investigational New Drug Application (IND)

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 312.20
  § 312.20 Requirement for an IND.
• 312.21
  § 312.21 Phases of an investigation.
• 312.22
  § 312.22 General principles of the IND submission.
• 312.23
  § 312.23 IND content and format.
• 312.30
  § 312.30 Protocol amendments.
• 312.31
  § 312.31 Information amendments.
• 312.32
  § 312.32 IND safety reporting.
• 312.33
  § 312.33 Annual reports.
• 312.38
  § 312.38 Withdrawal of an IND.