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Zdrowie i gospodarka · 20.10.2017

Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on generic tiotropium bromide inhalation powder entitled "Draft Guidance on Tiotropium Bromide." The draft guidance, when finalized, will provide product- specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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.

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