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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter F - Biologics |
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Part 601 - Licensing |
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Subpart H - Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible |
§ 601.93 - Postmarketing safety reporting.
Latest version.
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§ 601.93 Postmarketing safety reporting.
Biological products approved under this subpart are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.