# Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Draft Guidance for Industry - FDA Guidance Document Source: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-draft-guidance-for-industry/72d47f74-c8a1-4b7b-8d10-222b23fcd90c > FDA guidance document: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Draft Guidance for Industry. Issue date: April 14, 2022. Get complete insights and analysis. --- ## Details - Title: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Draft Guidance for Industry - Communication Type: Guidance Document - Product Type: drugs - Office Name: Center for Drug Evaluation and Research - Office URL: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: 2022-04-14 - Last Changed: 2022-05-19 - Docket Number: FDA-2022-D-0108 ## Related Documents - [Clinical Pharmacology Considerations for Peptide Drug Products](https://www.globalkeysolutions.net/guidances/guidance-document/clinical-pharmacology-considerations-for-peptide-drug-products/1609c8ed-4d50-4235-8a00-9c63176affe8) - [In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs](https://www.globalkeysolutions.net/guidances/guidance-document/in-vitro-release-test-studies-for-topical-drug-products-submitted-in-andas/c7ff8356-0869-42f7-a5dc-76e32fe0380b) - [Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/assessing-adhesion-with-transdermal-and-topical-delivery-systems-for-andas-draft-guidance-for-industry/2987a560-17ed-4e62-b674-1c17e17f5298)