The Food and Drug Administration has launched web versions of four forms for companies submitting or amending tobacco product applications.
The forms, part of the agency’s upgraded CTP Portal Next Generation, let applicants create, validate and submit premarket tobacco product applications (PMTAs) and Substantial Equivalence (SE) Reports entirely online, the agency said Wednesday.
Features of the web versions include:
- Step-by-step instructions on completing the forms
- A more user-friendly interface that helps guide applicants through the submission process
- The ability for multiple users to work on a submission at the same time and easily save drafts
- Real-time, automatic validation, ensuring all required fields are completed before submission
The FDA said the web-based forms include FDA 4057, 4057a, 3965 and 3965a.
Industry stakeholders with active Center for Tobacco Products (CTP) portal accounts had the option to test and provide feedback during development, the agency said.
PDF versions of the PMTA and SE Report forms are still available online, the FDA said, but starting Jan. 2, applicants who use the PDF versions must use the latest version of the forms in their PMTA and SE Report submissions.
“Creating these web-based forms is part of the FDA’s work to promote efficiency, effectiveness, and transparency to improve its tobacco product application review process,” the agency said in a statement.
For submission types other than PMTAs and SE Reports—such as Exemption Requests, Harmful and Potentially Harmful Constituents reports and Tobacco Product Ingredient Listings—the existing process using the FDA’s eSubmitter tool will continue, the agency said.
The FDA said it developed the PMTA and SE Report web-based forms first because they are some of the most commonly used forms.
The agency plans to introduce additional web forms for other submission types in future phases.
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