FDA action on an application.

21 C.F.R. § 1114.29
in effectEffective: 2024-07-01
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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.

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