Perspective: FDA’s Preparations for the September 9 Submission Deadline | FDA

Perspective: FDA’s Preparations for the September 9 Submission Deadline | FDA

Perspective from the CTP Director: FDA’s Preparations for the Sept. 9 Submission Deadline

Today, FDA Center for Tobacco Products (CTP) Director Mitch Zeller published a perspective piece on preparations that the center has been taking for the upcoming Sept. 9, 2020 premarket review submission deadline for deemed new tobacco products and the guiding principles for allocating product review resources. As the result of a court order (and a subsequent extension due to the unique circumstances of the COVID-19 pandemic), applications for deemed new tobacco products on the market as of Aug. 8, 2016 are due to FDA by Sept. 9, 2020. The court order also provided a one-year period during which products with timely-filed applications might remain on the market pending FDA review.  Director Zeller’s statement covers several important topics, such as:  The importance of the upcoming deadline CTP’s expectations of applications coming in by Sept. 9 Preparations the center has made to receive and process the expected applications efficiently How the center plans to handle the review of this large influx of applications

Since Congress authorized FDA to regulate tobacco products in 2009, CTP’s staff has increased from just a handful to over 950 today. During that time, CTP has built product review expertise and refined its premarket review processes, enhanced technical capabilities, issued rules and guidances, met with stakeholders to get a better understanding of tobacco products and applicants’ needs for information about the process, invested in tobacco product research, and provided resources to help industry prepare and submit premarket applications. These actions have prepared the center to receive, process, and review applications in a timely manner. FDA strives to review as many applications as possible during this one-year period and the agency has been developing a review process aimed at maximizing the number of products reviewed while ensuring the greatest public health impact. As always, FDA intends to be fair in allocating resources to reviewing different types of applications—for different types of products and companies—and as transparent as possible while meeting all necessary requirements. FDA plans to update the public and release information regularly as the agency refines plans for allocating product review resources and the process by which products would move into scientific review.