Code of Federal Regulations (Last Updated: April 5, 2024) |
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 |
Subpart D - FDA Action on Applications and Abbreviated Applications |
§ 314.152 - Notice of withdrawal of approval of an application or abbreviated application for a new drug.
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§ 314.152 Notice of withdrawal of approval of an application or abbreviated application for a new drug.
If the Food and Drug Administration withdraws approval of an application or abbreviated application for a new drug, FDA will publish a notice in the Federal Register announcing the withdrawal of approval. If the application or abbreviated application was withdrawn for grounds described in § 314.150(a) or § 314.151, the notice will announce the removal of the drug from the list of approved drugs published under section 505(j)(6) of the act and shall satisfy the requirement of § 314.162(b).
[57 FR 17994, Apr. 28, 1992]