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(2) An applicant may perhaps include content within a submission by cross-reference to a tobacco merchandise learn file or possibly a pending modified hazard tobacco products software for the same tobacco merchandise. Applicants using a learn file should give documentation in their ideal of reference for the learn file and clearly discover the particular written content remaining incorporated in the PMTA submission.
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“Wise 词汇”：相关单词和短语 Excited, intrigued and enthusiastic abubble aflutter agog all of a flutter idiom amped entranced evangelical evangelistic evangelistically excited go ahead phrasal verb lean lean in direction of sth phrasal verb make (all) the best, proper, and many others.
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(4) A concluding dialogue describing how the info and data contained during the PMTA each constitute legitimate scientific evidence and set up that allowing internet marketing of the new tobacco products is suitable for the security of the public well being, as decided with respect for the threats and Gains to your population in general, together with end users and nonusers of the tobacco products.
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(2) The anticipated natural here development of any underlying ailment, ailment, or affliction with the individuals(s) encountering the adverse experience and the person's predisposing hazard element profile for the adverse knowledge; or
The FDA considers a number of important components mainly because it critiques whether or not to approve the sale of a whole new or modified tobacco merchandise. They include things like:
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indicates all labels as well as other written, printed, or graphic make a difference on any report or any of its containers or wrappers, or accompanying these kinds of write-up.