federal_register: 2017-22734

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2017-22734 Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on generic tiotropium bromide inhalation powder entitled "Draft Guidance on Tiotropium Bromide." The draft guidance, when finalized, will provide product- specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for tiotropium bromide inhalation powder. 2017-10-20 2017 10 https://www.federalregister.gov/documents/2017/10/20/2017-22734/product-specific-guidance-for-tiotropium-bromide-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2017-10-20/pdf/2017-22734.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on generic tiotropium bromide inhalation powder entitled "Draft Guidance on Tiotropium Bromide." The draft guidance, when finalized, will...

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