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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 I — Expanded Access to Investigational Drugs for Treatment Use
Federal (United States) · Regulations
Subpart I — Expanded Access to Investigational Drugs for Treatment Use
3 sections
3 sections
21 C.F.R. § 312.305
Requirements for all expanded access uses.
21 C.F.R. § 312.315
Intermediate-size patient populations.
21 C.F.R. § 312.320
Treatment IND or treatment protocol.
Subpart I — Expanded Access to Investigational Drugs for Treatment Use | Federal (United States) Regulations | Justis AI