21 CFR 314.65
§ 314.65 Withdrawal by the applicant of an unapproved application.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 314.65, § 314.65 Withdrawal by the applicant of an unapproved application, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86339
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Full text
An applicant may at any time withdraw an application that is not yet approved by notifying the Food and Drug Administration in writing. If, by the time it receives such notice, the agency has identified any deficiencies in the application, we will list such deficiencies in the letter we send the applicant acknowledging the withdrawal. A decision to withdraw the application is without prejudice to refiling. The agency will retain the application and will provide a copy to the applicant on request under the fee schedule in § 20.45 of FDA's public information regulations.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.