Code of Federal Regulations · Subpart

Subpart B — Investigational New Drug Application (ind)

21 C.F.R. pt. 312, subpt. B

• § 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