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Zdrowie i gospodarka · 22/12/2021

Validation and Verification of Analytical Testing Methods Used for Tobacco Products; Draft Guidance for Industry; Availability; Request for Comments

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Validation and Verification of Analytical Testing Methods used for Tobacco Products" and requesting comments, including scientific and other information, concerning the recommendations set forth in the draft guidance. The draft guidance, when finalized, would provide information and recommendations related to the validation and verification of analytical test methods, including analytical testing of tobacco product constituents, ingredients, and additives, as well as stability testing of tobacco products. This draft guidance would help industry produce more consistent and reliable analytical data used to support regulatory submissions for finished tobacco products.

Source: Federal Register — Food and Drug AdministrationOpen original release →