federal_register: 2015-05023

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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
2015-05023 Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions." This guidance provides information in response to questions that FDA has received from manufacturers on demonstrating the substantial equivalence of a new tobacco product, including questions on when a modification to the label requires a premarket submission and review by FDA. 2015-03-05 2015 3 https://www.federalregister.gov/documents/2015/03/05/2015-05023/demonstrating-the-substantial-equivalence-of-a-new-tobacco-product-responses-to-frequently-asked https://www.govinfo.gov/content/pkg/FR-2015-03-05/pdf/2015-05023.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions." This guidance provides...  

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