# Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-waiver-requests-for-ph-adjusters-in-generic-drug-products-intended-for-parenteral-ophthalmic-or-otic-use-guidance-for-industry/40969c10-8c6c-42cb-b3eb-03f03eb9fa38

> FDA guidance document: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use:  Guidance for Industry. Issue date: November 17, 2025. Get complete insights and analysis.

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## Details

- Title: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2025-11-17
- Last Changed: 2025-11-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2022-D-0108">FDA-2022-D-0108</a>

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