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The final rule also points out how applicants may well submit a supplemental PMTA or possibly a resubmission, which might make improvements to performance in specific conditions by not necessitating applicants to resubmit duplicative information.

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Solutions observed on this Web page can expose you to formaldehyde, which is known on the Point out of California to bring about birth defects.

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(xi) A list of contractors who participated within the research, the part of each and every contractor, as well as initiation and termination dates with the participation of every contractor;

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WARNING: Use of the merchandise exposes buyers to substances like nicotine, determined by the Condition of California as a possible reason for cancer and reproductive destruction.

WARNING: This merchandise contains chemical compounds, which include nicotine, which is understood towards the State of California to result in cancer and reproductive damage.

As an example, a supplemental PMTA could be submitted when an applicant is searching for authorization for just a modified Variation of the tobacco product or service for which they've by now been given a PMTA promoting granted order.

Applicants that have received a marketing granted order for the tobacco product may possibly, in its place structure of publishing an software that meets the content demands of § 1114.7, post a supplemental PMTA to seek advertising and marketing authorization for modifications to these merchandise, which result in a new tobacco product or service underneath segment 910(a)(one) of the Federal Meals, Drug, and Cosmetic Act. Supplemental PMTAs will have to include new info concerning modifications that build the new tobacco item but enable the applicant to fulfill the remaining application specifications by cross-referencing relevant articles within the Formerly submitted PMTA for the original tobacco product or service.

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