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Title 21

Displaying title 21, up to date as of 8/06/2026. Title 21 was last amended 8/06/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter FBiologics600 – 680
Part 601Licensing601.2 – 601.95
Subpart AGeneral Provisions601.2 – 601.9
Subpart B [Reserved]
Subpart CBiologics Licensing601.12 – 601.29
Subpart DDiagnostic Radiopharmaceuticals601.30 – 601.35
§ 601.30Scope.
§ 601.31Definition.
§ 601.32General factors relevant to safety and effectiveness.
§ 601.33Indications.
§ 601.34Evaluation of effectiveness.
§ 601.35Evaluation of safety.
Subpart EAccelerated Approval of Biological Products for Serious or Life-Threatening Illnesses601.40 – 601.46
Subpart FConfidentiality of Information601.50 – 601.51
§ 601.50Confidentiality of data and information in an investigational new drug notice for a biological product.
§ 601.51Confidentiality of data and information in applications for biologics licenses.
Subpart GPostmarketing Studies601.70
§ 601.70Annual progress reports of postmarketing studies.
Subpart HApproval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible601.90 – 601.95
§ 601.90Scope.
§ 601.91Approval based on evidence of effectiveness from studies in animals.
§ 601.92Withdrawal procedures.
§ 601.93Postmarketing safety reporting.
§ 601.94Promotional materials.
§ 601.95Termination of requirements.