§ 1114.29. FDA action on an application.
84 words·~1 min read·
/us/cfr/t21/s§ 1114.29·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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.