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# Stakeholder Technical Issues with Ophthalmic Guide
- URL: https://www.fdaweb.com/stakeholder-technical-issues-with-ophthalmic-guide/
- Published: 2023-12-14T12:00:00.000Z
- Updated: 2026-09-14T14:18:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156002

Four stakeholders are raising technical questions, concerns, requests for clarification, and comments on an FDA draft guidance on quality considerations for topical ophthalmic drug products. In its [comment](https://www.regulations.gov/comment/FDA-2023-D-4177-0016?ref=fdaweb.com), the Consumer Healthcare Products Association says it respects the need for the guidance, especially given recent global concerns about contaminated ophthalmic drug products. It says it encourages all manufacturers to implement and understand applicable regulations for their products in addition to using FDA resources and previously released guidance related to sterile/aseptic manufacturing and product quality.

Also providing specific, technical comments were [Alcon](https://www.regulations.gov/comment/FDA-2023-D-4177-0018?ref=fdaweb.com), [Bausch & Lomb](https://www.regulations.gov/comment/FDA-2023-D-4177-0015?ref=fdaweb.com), and [Sandoz](https://www.regulations.gov/comment/FDA-2023-D-4177-0017?ref=fdaweb.com).