Zdrowie i gospodarka · 18.11.2020
Product-Specific Guidance for Tiotropium Bromide; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry, entitled "Draft Guidance for Tiotropium Bromide." The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to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.