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According to the PMTA rule, Premarket Tobacco Product Applications and Recordkeeping Requirements, a supplemental PMTA : May be submitted in situations where an applicant is seeking authorization for a new tobacco product that is a modified version of a previously authorized tobacco product May be submitted for modifications of a previously authorized tobacco product in order to demonstrate compliance with a tobacco product standard under section 907 of the FD&C Act Allows the applicant to cross-reference applicable content from the previously submitted PMTA that received the marketing granted order Must include a section containing full descriptions, data, and information of each modification to the new product, comparisons to the original product version, and a concluding summary of how the new product meets the requirements to receive a marketing granted order According to the PMTA rule, a resubmission : May be submitted to address application deficiencies following the issuance of a marketing denial order May be for the same tobacco product which FDA issued a marketing denial order or a new tobacco product that results from modifications to the product necessary to address the deficiencies outlined in the marketing denial order Allows the applicant to cross-reference content from the previously submitted PMTA that received the marketing denial order Must include a section that lists and provides a separate response to each deficiency, including all data and information necessary to complete each response Both supplemental PMTAs and resubmissions must include the following required FDA forms: Form FDA 4057 Premarket Tobacco Product Application (PMTA) Submission Complete this form directly in CTP Portal NextGen to help ensure a more user-friendly and efficient application submission process
Shuai K, Ziemiecki A, Wilks AF, Harpur AG, Sadowski HB, Gilman MZ, Darnell JE
