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The final rule also explains how applicants may possibly post a supplemental PMTA or a resubmission, which would make improvements to performance in specified situations by not requiring applicants to resubmit duplicative info.
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(B) The toxicological profile of The brand new tobacco merchandise relevant to the route of administration, such as the genotoxicity, carcinogenicity, reproductive toxicity, immunotoxicity, acute toxicity, and repeat dose (chronic) toxicity of the new tobacco item relative to other tobacco products. The toxicological profile also features info on the toxicity of your substances, additives, and HPHCs, relative to your route of administration plus the choice of prospective levels of exposure resulting from the use of, or exposure to, The brand new tobacco merchandise, which include studies which explore the toxicological consequences of any leachables and extractables which will surface within the container closure method as well as the component combination, for example additive or synergistic effects;
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WARNING: This merchandise incorporates chemical compounds, including nicotine, which is known towards the Point out of California to bring about cancer and reproductive harm.
Host name displays while in the tab at the best of your browser for faster navigation concerning multiple PMTA cases.
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As an example, a supplemental PMTA may very well be submitted when an applicant is looking for authorization for any modified Edition of the tobacco solution for which they've got previously acquired a PMTA advertising granted buy.
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suggests an assembly of substances. Elements are assembled to sort a tobacco product or parts or parts of a tobacco product.