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314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.

Current through Sep 8, 2026 · Read all of Part 314

⚠ 4 pending changes to Part 314

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the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval.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]

← § 314.153 Suspension of approval of an abbreviated new drug application.§ 314.161 Determination of reasons for voluntary withdrawal of a listed drug. →