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FDA (CDER)
GUIDANCE FINAL
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry
Published: 11/17/2025Detected: 3/20/2026

Summary preview

Clarifies the documentation and justification expectations for requesting waivers related to pH adjusters in generic drug products intended for parenteral, ophthalmic, or otic use.

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ophthalmology
manufacturing
quality
clinical
safety
labeling
#generic drugs
#pH adjusters
#parenteral
#ophthalmic
#otic

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