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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 601 — LICENSING
Subpart H — Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible
Federal (United States) · Regulations
Subpart H — Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible
6 sections
6 sections
21 C.F.R. § 601.90
Scope.
21 C.F.R. § 601.91
Approval based on evidence of effectiveness from studies in animals.
21 C.F.R. § 601.92
Withdrawal procedures.
21 C.F.R. § 601.93
Postmarketing safety reporting.
21 C.F.R. § 601.94
Promotional materials.
21 C.F.R. § 601.95
Termination of requirements.
Subpart H — Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible | Federal (United States) Regulations | Justis AI