Notice 21 May 2025 healthcare, regulation, fda, generic drugs, bioequivalence, fluticasone

💊FDA Draft Guidance on Fluticasone Propionate Impacting Generic Drugs

The Food and Drug Administration (FDA or Agency) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Fluticasone Propionate." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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 fluticasone propionate nasal spray, metered.

Learn More