FDA Releases New Resources for PMTA Amendments

Apr.13.2023

FDA provides resources to help prepare and submit revised PMTAs for tobacco products, including a guide and video tutorial.

The U.S. Food and Drug Administration's Center for Tobacco Products (CTP) has released two new resources to assist applicants in preparing and submitting revised pre-market tobacco product applications (PMTAs).

Explanation - Revision Note: Completion of FDA Form 4057a", "Video - Utilizing CTP Portal Website

The disclosure document provides a quick guide for filling out the FDA 4057a form for revising pre-market tobacco product applications and submitting general correspondence.

In most cases, the CTP can only review PMTA revisions that include the FDA 4057a form. When submitting a PMTA revision, the FDA will first review the required FDA 4057a form. If necessary information is missing from the form, the FDA may not continue with the review of the revision.

The video provides an overview of the CTP portal website and how to use it, including how to search for and track application submission numbers online.

References:

Newly Available Tools to Aid in PMTA Amendment Submission.

The video of the FDA tobacco compliance webinar.

Amendment Tips: How to fill out Form FDA 4057a.

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