§1114.29. FDA action on an application.

21 C.F.R. § 1114.29

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.

Notes, amendments, and revision history

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.