View all text of Subpart C [§ 1114.25 - § 1114.37]

§ 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.