Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024
§ 1114.29 - FDA action on an application.

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.

authority: 21 U.S.C. 371,374,387a,387i,387j; Pub. L. 117-103, 136 Stat. 49
source: 86 FR 55412, Oct. 4, 2021, unless otherwise noted.
cite as: 21 CFR 1114.29