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FDA Finalizes Guidance on Generic Drug Adjuster Waivers
November 23, 2025

WASHINGTON, Nov. 23 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration announced the availability of a final guidance document for industry. This document entitled "Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use," will assist applicants seeking approval for generic drugs meant for injection, eyes, or ears.

The guidance is relevant for abbreviated drug applic . . .

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