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Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses | Midpage
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Code of Federal Regulations
Title 21
Chapter I
Subchapter D
Part 312
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.