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

1. CFR
2. ›
3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 312
8. ›
9. Subpart E

Sections

• 312.80
  § 312.80 Purpose.
• 312.81
  § 312.81 Scope.
• 312.82
  § 312.82 Early consultation.
• 312.83
  § 312.83 Treatment protocols.
• 312.84
  § 312.84 Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
• 312.85
  § 312.85 Phase 4 studies.
• 312.86
  § 312.86 Focused FDA regulatory research.
• 312.87
  § 312.87 Active monitoring of conduct and evaluation of clinical trials.
• 312.88
  § 312.88 Safeguards for patient safety.