Code of Federal Regulations · Subpart

Subpart E — Drugs Intended To Treat Life-threatening And Severely-debilitating Illnesses

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

• § 312.80 Purpose
• § 312.81 Scope
• § 312.82 Early Consultation
• § 312.83 Treatment Protocols
• § 312.84 Risk-benefit Analysis In Review Of Marketing Applications For Drugs To Treat Life-threatening And Severely-debilitating Illnesses
• § 312.85 Phase 4 Studies
• § 312.86 Focused Fda Regulatory Research
• § 312.87 Active Monitoring Of Conduct And Evaluation Of Clinical Trials
• § 312.88 Safeguards For Patient Safety