federal_register: 2015-22494

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-22494 Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Second Edition; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing a second edition of the guidance for industry entitled "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions". FDA is issuing the second edition to provide further information on demonstrating substantial equivalence (SE) of a new tobacco product, including demonstrating SE when the new tobacco product has: A modified label that renders it distinct from, but has identical characteristics to, a valid predicate product; or a change in product quantity from, but where the per weight composition is identical to, a valid predicate product. 2015-09-08 2015 9 https://www.federalregister.gov/documents/2015/09/08/2015-22494/demonstrating-the-substantial-equivalence-of-a-new-tobacco-product-responses-to-frequently-asked https://www.govinfo.gov/content/pkg/FR-2015-09-08/pdf/2015-22494.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing a second edition of the guidance for industry entitled "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions". FDA is issuing the second edition...  

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