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Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on generic tiotropium bromide inhalation powder entitled "Draft Guidance on Tiotropium Bromide." The draft guidance, when finalized, will provide product- specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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