§314.152. Notice of withdrawal of approval of an application or abbreviated application for a new drug. — Inbound Citations
21 C.F.R. § 314.152
Statutory Authority
Cited by 2 regulations in release 2026-08-27.
Citations to 21 C.F.R. § 314.152 as a whole
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(5) If the final decision affirms the agency's initial decision that the listed drug was withdrawn for reasons of safety or effectiveness, the decision will be published in the Federal Register in compliance with § 314.152, and will, except as provided in paragraph (b)(6) of this section, suspend approval of all abbreviated new drug applications identified under paragraph (b)(1) of this section and remove from the list the listed drug and any drug whose approval was suspended under this paragraph. The notice will satisfy the requirement of § 314.162(b). The agency's final decision and copies of materials on which it relies will also be filed with the Dockets Management Staff (address in paragraph (b)(1) of this section).