21 CFR 314.152
§ 314.152 Notice of withdrawal of approval of an application or abbreviated application for a new drug.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 314.152, § 314.152 Notice of withdrawal of approval of an application or abbreviated application for a new drug, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86373
- Permanent ID
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Full text
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 If the application or abbreviated application was withdrawn for grounds described in § 314.150(a) or § 314.151, the notice will announce the removal of the drug from the list of approved drugs published under section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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.