21 CFR 314.160
§ 314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 314.160, § 314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86375
- Permanent ID
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Full text
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the basis of new data, approve an application or abbreviated application which it had previously refused, suspended, or withdrawn approval.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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.