Perspective from the CTP Director: FDA’s Progress on Sept. 9 Tobacco Product Applications

Perspective from the CTP Director: FDA's Progress on Review of Tobacco Product Applications Submitted by the Sept. 9, 2020 Deadline On Feb. 16, CTP Director Mitch Zeller published a perspective piece highlighting FDA's progress since the Sept. 9, 2020 premarket application deadline for certain deemed new tobacco products, such as cigars, hookah and electronic nicotine delivery systems (ENDS). This piece covers topics such as: FDA's progress on processing the submissions The volume of submissions received by the Agency The review process for the submissions, which may include acceptance, filing, and substantive review phases, and the progress we've made within each phase How FDA plans to allocate resources and determine the review order of timely-submitted applications To help fulfill our commitment to transparency during the review process, FDA has also created two new webpages with key information and data related to the Sept. 9 tobacco product applications: Deemed New Tobacco Product Applications List: This webpage includes a list of deemed new tobacco products that were on the U.S. market as of Aug. 8, 2016, are currently marketed, and for which a premarket application was submitted via the SE or EX REQ pathways by Sept. 9, 2020. Due to the size and volume of the PMTA submissions and the variable quality, format and presentation of these submissions, processing these submissions and verifying this information will take more time. We will post information on products submitted through the PMTA pathway as soon as possible. This webpage will also be updated periodically when listed products are the subject of a final action, such as a positive or negative order. Tobacco Product Applications: Metrics and Reporting: This webpage includes more detailed updates of the agency's progress on premarket application review than previously available, including metrics broken down by pathway (SE, EX REQ, and PMTA) and by product category type (e.g., cigarette, ENDS, cigars, smokeless). This page will also include updates on intermediate actions such as the number of applications received and accepted, as well as aggregate data on the completion of substantive review and the actions taken. FDA plans to update the metrics on the acceptance and filing phases every other month, and the metrics on the review and action phase once every quarter. The information on this page is replacing the data previously available on the Tobacco Products Marketing Order webpage, which has been updated to house the final marketing orders for each pathway in a more streamlined manner.

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