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U.S. Department of Health and Human Services

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Cumulative number of Regular SE Applications received since Program Inception

Dictionary: The Tobacco Control Act requires manufacturers of new or modified tobacco products to submit a premarket application and obtain a market authorization order before they market their products. To introduce a new or modified tobacco product, an applicant must submit an application to FDA providing information on the product sufficient to allow the agency to determine that an order authorizing the product’s introduction is appropriate for the protection of the public health.

Additional information about premarket review requirements for tobacco products can be found on the Tobacco Products - Product Requirements, Marketing and Labeling.

Information is current as of March 31, 2020. CTP began tracking this measure FY15 Q4.

Fiscal Year - 2020

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TimeTargetNumber
Oct 2019N/A3,061
Nov 2019N/A3,075
Dec 2019N/A3,119
Jan 2020N/A3,144
Feb 2020N/A3,189
Mar 2020N/A3,210
Apr 2020N/ATBD
May 2020N/ATBD
Jun 2020N/ATBD
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 3,210

Cumulative number of Regular SE Application Closed since Program Inception

FDA issued an Order letter, issued a Refuse-to-Accept letter or the application was withdrawn by the applicant.

Fiscal Year - 2020
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TimeTargetNumber
Oct 2019N/A2,886
Nov 2019N/A2,914
Dec 2019N/A2,934
Jan 2020N/A2,941
Feb 2020N/A2,949
Mar 2020N/A2,976
Apr 2020N/ATBD
May 2020N/ATBD
Jun 2020N/ATBD
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 2,976

Total number of Regular SE Applications received or filed in the month

Dictionary: The Tobacco Control Act requires manufacturers of new or modified tobacco products to submit a premarket application and obtain a market authorization order before they market their products. To introduce a new or modified tobacco product, an applicant must submit an application to FDA providing information on the product sufficient to allow the agency to determine that an order authorizing the product’s introduction is appropriate for the protection of the public health.

Additional information about premarket review requirements for tobacco products can be found on the Tobacco Products - Product Requirements, Marketing and Labeling.

Fiscal Year - 2020

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TimeTargetNumber
Oct 2019N/A18
Nov 2019N/A14
Dec 2019N/A44
Jan 2020N/A25
Feb 2020N/A45
Mar 2020N/A21
Apr 2020N/ATBD
May 2020N/ATBD
Jun 2020N/ATBD
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 167

Total number of Regular SE Applications Closed in the month

FDA issued an Order letter, issued a Refuse-to-Accept letter or the application was withdrawn by the applicant.

Fiscal Year - 2020
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TimeTargetNumber
Oct 2019N/A4
Nov 2019N/A28
Dec 2019N/A20
Jan 2020N/A7
Feb 2020N/A8
Mar 2020N/A27
Apr 2020N/ATBD
May 2020N/ATBD
Jun 2020N/ATBD
Jul 2020N/ATBD
Aug 2020N/ATBD
Sep 2020N/ATBD

FY 2020 YTD: 94

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

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