FDA Asks Tobacco Manufacturers to Participate in Pilot Program to Evaluate eSubmission Portal

February 18, 2016

FDA’s Center for Tobacco Products (CTP) is seeking up to six regulated tobacco manufacturers to participate in a voluntary pilot program to help evaluate a potential new eSubmission portal (CTP Portal). The Agency has designed the portal in an attempt to improve the process for sending certain regulatory submissions to CTP electronically.

In the Federal Register notice published February 17, 2016, the FDA stated that the “program is intended to provide CTP regulatory review staff with an opportunity to evaluate the CTP Portal, including its capability for sending and receiving secure messages and providing information as to the documents submitted to it.”

Interested parties should submit an electronic application no later than Wednesday, March 2, 2016, and user testing will being on or around March 18th.

Are you in the process of developing a tobacco product or do you already manufacture a tobacco product that is subject to FDA’s regulations? We are leaders in the developing category of tobacco related submissions.  To learn more about our services and how we can help your product successfully move through FDA, contact us today.

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