StacksVerified U.S. regulatory reference

21 CFR §1114.29

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
After receipt of an application, FDA will:
  1. (a)Refuse to accept the application as described in § 1114.27(a);
  2. (b)Issue a letter administratively closing the application;
  3. (c)Issue a letter canceling the application if FDA finds that it mistakenly accepted the application or that the application was submitted in error;
  4. (d)Refuse to file the application as described in § 1114.27(b);
  5. (e)Issue a marketing granted order as described in § 1114.31; or
  6. (f)Issue a marketing denial order as described in § 1114.33.