21 CFR 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.
Source:
53 FR 41523, Oct. 21, 1988, unless otherwise noted.