Subpart E. Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses

• § 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.