federal_register: 2021-16046

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2021-16046 Product-Specific Guidance for Olodaterol Hydrochloride; Tiotropium Bromide; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide." The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to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 olodaterol hydrochloride; tiotropium bromide inhalation spray. 2021-07-28 2021 7 https://www.federalregister.gov/documents/2021/07/28/2021-16046/product-specific-guidance-for-olodaterol-hydrochloride-tiotropium-bromide-draft-guidance-for https://www.govinfo.gov/content/pkg/FR-2021-07-28/pdf/2021-16046.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Draft Guidance for Olodaterol Hydrochloride; Tiotropium Bromide." The draft guidance, when finalized, will provide...

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