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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 |
Part 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
| Subpart A - General Information |
| § 99.1 - Scope. |
| § 99.3 - Definitions. |
| Subpart B - Information To Be Disseminated |
| § 99.101 - Information that may be disseminated. |
| § 99.103 - Mandatory statements and information. |
| § 99.105 - Recipients of information. |
| Subpart C - Manufacturer's Submissions, Requests, and Applications |
| § 99.201 - Manufacturer's submission to the agency. |
| § 99.203 - Request to extend the time for completing planned studies. |
| § 99.205 - Application for exemption from the requirement to file a supplemental application. |
| 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. |
| Subpart E - Corrective Actions and Cessation of Dissemination |
| § 99.401 - Corrective actions and cessation of dissemination of information. |
| § 99.403 - Termination of approvals of applications for exemption. |
| § 99.405 - Applicability of labeling, adulteration, and misbranding authority. |
| Subpart F - Recordkeeping and Reports |
| § 99.501 - Recordkeeping and reports. |