Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Drugs for Human Use
  6. Investigational New Drug Application
  7. Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses

Checkout our iOS App for a better way to browser and research.

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.