21 C.F.R. § 1114.29

Current through October 31, 2024
Section 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 .

21 C.F.R. §1114.29

86 FR 55300 , 11/4/2021