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the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval.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.
21 CFR Part 314 · Applications for FDA Approval to Market a New Drug
§ 314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn
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Amendment history
Federal Register documents that created or amended this section.
- 57 FR 17995 28 Apr 1992