Subpart E - DRUGS INTENDED TO TREAT LIFE-THREATENING AND SEVERELY-DEBILITATING ILLNESSES
- Section 312.80 - Purpose
- Section 312.81 - Scope
- Section 312.82 - Early consultation
- Section 312.83 - Treatment protocols
- Section 312.84 - Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses
- Section 312.85 - Phase 4 studies
- Section 312.86 - Focused FDA regulatory research
- Section 312.87 - Active monitoring of conduct and evaluation of clinical trials
- Section 312.88 - Safeguards for patient safety