21 CFR 1114.29

§ 1114.29 FDA action on an application.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 1114.29, § 1114.29 FDA action on an application, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91545
Permanent ID: ys:prov:91545@1
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Full text

After receipt of an application, FDA will: (a) Refuse to accept the application as described in § 1114.27(a); (b) Issue a letter administratively closing the application; (c) Issue a letter canceling the application if FDA finds that it mistakenly accepted the application or that the application was submitted in error; (d) Refuse to file the application as described in § 1114.27(b); (e) Issue a marketing granted order as described in § 1114.31; or (f) Issue a marketing denial order as described in § 1114.33.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.