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Code of Federal Regulations (Last Updated: November 8, 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 A - General |
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Part 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices |
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Subpart D - FDA Action on Submissions, Requests, and Applications |
| § 99.301 - Agency action on a submission. |
| § 99.303 - Extension of time for completing planned studies. |
| § 99.305 - Exemption from the requirement to file a supplemental application. |