FDA Creates Two New Resources to Help Prepare and Submit pMTA Applications
Today, on April 13, news reports that the U.S. Food and Drug Administration's Center for Tobacco Products (CTP) has created two new resources to assist applicants in preparing and submitting amendments to their Premarket Tobacco Product Applications (PMTA): a briefing document—Amendment Tips: Completing Form FDA 4057a and a video—Using the CTP Portal.
The briefing document provides quick tips for completing the FDA 4057a form for PMTA amendments and general correspondence submissions. In most cases, the CTP can only accept PMTA amendments for review that include the FDA 4057a form. Generally, when submitting amendments to a PMTA, the FDA will first review the required FDA 4057a form. If the form is missing required content, the FDA may not continue reviewing the amendment.
The video outlines the CTP portal and how to use it, including how to find the application submission tracking number online.
Recently, CTP Director Brian King outlined several new initiatives aimed at improving the center's efficiency, effectiveness, and transparency. These activities include enhancing communication regarding scientific issues and practices. By providing these new resources, the CTP aims to better support applicants in successfully navigating the PMTA process.
