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Title 21

Displaying title 21, up to date as of 9/15/2021. Title 21 was last amended 9/13/2021.

Title 21

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§ 314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.

Upon the Food and Drug Administration's own initiative or upon request of an applicant, FDA may, on the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval. FDA will publish a notice in the Federal Register announcing the approval.

[57 FR 17995, Apr. 28, 1992]