SUBPART B—Investigational New Drug Application (IND) (§312.20 to §312.38)
- 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.