federal_register: 2020-25412

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2020-25412 Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry, entitled "Draft Guidance for Tiotropium Bromide." The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for tiotropium bromide inhalation spray. 2020-11-18 2020 11 https://www.federalregister.gov/documents/2020/11/18/2020-25412/product-specific-guidance-for-tiotropium-bromide-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2020-11-18/pdf/2020-25412.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry, entitled "Draft Guidance for Tiotropium Bromide." The draft guidance, when finalized, will provide product-specific recommendations...

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