SUBPART E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses (§312.80 to §312.88)
- 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.