Current through September 30, 2024
Section 1114.29 - FDA action on an applicationAfter 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 .