§ 1114.29 FDA action on an application.
Current through Sep 8, 2026 · Read all of Part 1114
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.