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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter K - Tobacco Products |
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Part 1114 - Premarket Tobacco Product Applications |
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Subpart C - FDA Review |
§ 1114.29 - FDA action on an application.
Latest version.
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§ 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.