21 CFR Subpart E
Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
June 25, 2020
§
312.86
Focused FDA regulatory research
§
312.87
Active monitoring of conduct and evaluation of clinical trials
§
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
§
312.88
Safeguards for patient safety
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