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.
Recently Released Final Rule Extends FDA’s Authority to ALL Tobacco Products
On May 5, 2016, the FDA published a final rule, extending the Agency’s authority to all tobacco products, including, but not limited to, e-cigarettes, cigars, and hookah and pipe tobacco. This rule,...
FDA - Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies
FDA - Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies. August 2022 This final guidance is intended to help applicants (or “you”) design and...