Code of Federal Regulations · Part

Part 312 — Investigational New Drug Application

21 C.F.R. pt. 312

• Subpart A General Provisions
• Subpart B Investigational New Drug Application (ind)
• Subpart C Administrative Actions
• Subpart D Responsibilities Of Sponsors And Investigators
• Subpart E Drugs Intended To Treat Life-threatening And Severely-debilitating Illnesses
• Subpart F Miscellaneous
• Subpart G Drugs For Investigational Use In Laboratory Research Animals Or In Vitro Tests
• Subpart H Subpart H [reserved]
• Subpart I Expanded Access To Investigational Drugs For Treatment Use