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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 June 30, 2019. CTP began tracking this measure FY15 Q4.

Fiscal Year - 2019

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TimeTargetNumber
Oct 2018N/A2,772
Nov 2018N/A2,814
Dec 2018N/A2,835
Jan 2019N/A2,847
Feb 2019N/A2,851
Mar 2019N/A2,874
Apr 2019N/ATBD
May 2019N/ATBD
Jun 2019N/ATBD
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 2,874

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FDA issued an Order letter, issued a Refuse-to-Accept letter or the application was withdrawn by the applicant.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 - 2019
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TimeTargetNumber
Oct 2018N/A2,616
Nov 2018N/A2,638
Dec 2018N/A2,648
Jan 2019N/A2,673
Feb 2019N/A2,724
Mar 2019N/A2,738
Apr 2019N/A2,757
May 2019N/A2,769
Jun 2019N/A2,791
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 2,791

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 - 2019

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TimeTargetNumber
Oct 2018N/A18
Nov 2018N/A42
Dec 2018N/A21
Jan 2019N/A12
Feb 2019N/A4
Mar 2019N/A29
Apr 2019N/A32
May 2019N/A7
Jun 2019N/A63
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 228

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 - 2019
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TimeTargetNumber
Oct 2018N/A6
Nov 2018N/A22
Dec 2018N/A10
Jan 2019N/A25
Feb 2019N/A51
Mar 2019N/A14
Apr 2019N/A19
May 2019N/A12
Jun 2019N/A22
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 181

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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