Part 312 — Investigational New Drug Application

Search Part 312 full text →

• Subpt. A General Provisions §§312.1 to 312.10
• Subpt. B Investigational New Drug Application (IND) §§312.20 to 312.38
• Subpt. C Administrative Actions §§312.40 to 312.48
• Subpt. D Responsibilities of Sponsors and Investigators §§312.50 to 312.70
• Subpt. E Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses §§312.80 to 312.88
• Subpt. F Miscellaneous §§312.110 to 312.145
• Subpt. G Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests §312.160
• Subpt. H Subpart H [Reserved]
• Subpt. I Expanded Access to Investigational Drugs for Treatment Use §§312.300 to 312.320