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(two) The application must incorporate the subsequent sections by cross-reference to the PMTA for the original tobacco product or service and incorporate any supplemental data that is essential to supplement or update the cross-referenced details:
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An applicant may possibly, as a substitute format of submitting an software that meets the information specifications of § 1114.seven or 1114.15 (if applicable), submit a resubmission to handle deficiencies established forth inside of a internet marketing denial get. The resubmission should incorporate new facts important to address software deficiencies and cross-reference applicable content material with the PMTA that received the advertising and marketing denial purchase.
WARNING: This solution contains chemical compounds, like nicotine, which is known to your Condition of California to trigger cancer and reproductive damage.
The entire report of every study included in the application must describe the precise products analyzed and involve the next goods, the place relevant and also to the extent reasonably readily available.
(1) Comprehensive descriptions of each and every modification to your merchandise and comparisons to the original products Model described within the previously licensed PMTA;
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The application should include an Evaluation and discussion of how the info and information contained in the appliance build that permitting the tobacco product to generally be marketed will be appropriate for the protection of community overall health established with regard to the population in general, together with users and nonusers from the tobacco item.
Output Deficiency letter: Added information and facts is necessary to finish scientific overview. The letter will specify the amount of times an applicant has to reply.
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