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Title 21 - Food and Drugs
Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Subchapter D - DRUGS FOR HUMAN USE
Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
21 CFR Subpart I
21 CFR Subpart I
Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
June 25, 2020
§
314.600
Scope
§
314.610
Approval based on evidence of effectiveness from studies in animals
§
314.620
Withdrawal procedures
§
314.630
Postmarketing safety reporting
§
314.640
Promotional materials
§
314.650
Termination of requirements
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