C.F.R. » Title 21 » 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

21 C.F.R. § 314.152

Notice of withdrawal of approval of an application or abbreviated application for a new drug

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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 If the application or abbreviated application was withdrawn for grounds described in § 314.150(a) or § 314.151, the notice will announce the removal of the drug from the list of approved drugs published under section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]
Notes of Decisions
Cited in 1 case (1 in the last 5 years), 2024–2024 · leading case: Vanda Pharm. Inc. v. Food & Drug Admin., No. 2023-2812 (D.D.C. Sept. 10, 2024).
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Vanda Pharm. Inc. v. Food & Drug Admin., No. 2023-2812 (D.D.C. Sept. 10, 2024). “” 21 C.F.R § 314.152; see Opp’n at 16–18. The “incurably premature” doctrine is not rigidly formalist, however.”
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