§ 314.152. Notice of withdrawal of approval of an application or abbreviated application for a new drug.
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/us/cfr/t21/s§ 314.152·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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 If the application or abbreviated application was withdrawn for grounds described in § 314.150(a) or § 314.151, the notice will announce the removal of the drug from the list of approved drugs published under section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]