Zdrowie i gospodarka · 17/11/2025

FDA Releases Guidance on Waiver Requests for pH Adjusters in Generic Drug Products

The FDA has released a final guidance for industry on considering waiver requests for pH adjusters in generic drug products intended for parenteral, ophthalmic, or otic use, aimed at assisting ANDA applicants seeking approval for drugs with qualitative or quantitative differences from reference listed drugs.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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