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LII
Electronic Code of Federal Regulations (e-CFR)
Title 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F—BIOLOGICS
PART 601—LICENSING
Subpart H—Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible
21 CFR Subpart H - Subpart H—Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible
CFR
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§ 601.90 Scope.
§ 601.91 Approval based on evidence of effectiveness from studies in animals.
§ 601.92 Withdrawal procedures.
§ 601.93 Postmarketing safety reporting.
§ 601.94 Promotional materials.
§ 601.95 Termination of requirements.
Source:
67 FR 37996
, May 31, 2002, unless otherwise noted.
