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Notice

Product-Specific Guidance on Fluticasone Propionate; Draft Guidance for Industry; Availability

Notice of availability.

📖 Research Context From Federal Register API

Summary:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a new draft guidance for industry entitled "Draft Guidance on Fluticasone Propionate." The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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

Key Dates
Citation: 90 FR 21781
Submit either electronic or written comments on the draft guidance by July 21, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Comments closed: July 21, 2025
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Document Details

Document Number2025-09067
FR Citation90 FR 21781
TypeNotice
PublishedMay 21, 2025
Effective Date-
RIN-
Docket IDDocket No. FDA-2007-D-0369
Pages21781–21782 (2 pages)
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