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.

TAGS:

February 1, 2017

FDA Extends Effective Date for its Refuse to Accept Policy for Premarket Tobacco Product Submissions

On August 8, 2016, the FDA issued a final rule outlining its refuse to accept policy for premarket tobacco product submissions failing to meet the minimum threshold of acceptability for FDA review....

Tobacco sticking out of cigarettes

December 1, 2015

FDA Extends Comment Period for Proposed Regulation of Intended Uses of Tobacco Products

On September 25, 2015, FDA published a notice of proposed rulemaking (NPRM) regarding the regulation of products made or derived from tobacco. In the Federal Register announcement, "FDA requested...

August 10, 2016

FDA Issues Final Rule Regarding its Refuse to Accept Procedures for Premarket Tobacco Product Submissions

On Monday, August 8th, the FDA issued a final rule outlining its refuse to accept policy for tobacco product submissions that do not meet the minimum threshold for acceptability for FDA review....