Code of Federal Regulations > Title 21 > Chapter I > Part 312 > Subpart E - Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

§ 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.