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an Modification which contains sizeable new data from a Earlier unreported study, in-depth new analyses of Beforehand submitted data, or sizeable new manufacturing information), FDA will restart the 180-day review period immediately after receipt of your amendment.
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(ii) Entirely supplies an exterior heat resource to initiate but not keep combustion of a tobacco solution.
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The FDA has finalized this rule soon after receiving and reviewing opinions during the public remark period for your proposed rule, issued on Sept.
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The ultimate rule describes the knowledge an applicant will have to consist of within a PMTA to the FDA to finish a substantive overview of the application.
(vii) Finish descriptions of any using tobacco or aerosol-generating regimens used for analytical testing that are not standardized or broadly acknowledged with the scientific community, if applicable.
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