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US law
Federal (United States)
Regulations
Title 21 CFR — Food and Drugs
Chapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part 312 — INVESTIGATIONAL NEW DRUG APPLICATION
Subpart E — Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
Federal (United States) · Regulations
Subpart E — Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
5 sections
5 sections
21 C.F.R. § 312.82
Early consultation.
21 C.F.R. § 312.85
Phase 4 studies.
21 C.F.R. § 312.86
Focused FDA regulatory research.
21 C.F.R. § 312.87
Active monitoring of conduct and evaluation of clinical trials.
21 C.F.R. § 312.88
Safeguards for patient safety.
Subpart E — Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses | Federal (United States) Regulations | Justis AI