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# Questions on Topical Ophthalmic Draft Guide
- URL: https://www.fdaweb.com/questions-on-topical-ophthalmic-draft-guide/
- Published: 2024-02-28T12:00:00.000Z
- Updated: 2026-09-14T14:24:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156444

The Association for Accessible Medicines raises these [concerns](https://www.regulations.gov/comment/FDA-2023-D-4177-0039?ref=fdaweb.com) about an FDA draft guidance on quality considerations for topical ophthalmic drug products:

- identification and qualification thresholds;
- validation of analytical methods for extractables; and
- acceptance criteria for leachables.

Alcon [updates](https://www.regulations.gov/comment/FDA-2023-D-4177-0036?ref=fdaweb.com) its comments, questions, requests for clarification, and general comments in a table based on the latest draft of the guidance published 12/27/2023.

Bausch & Lomb also [updates](https://www.regulations.gov/comment/FDA-2023-D-4177-0037?ref=fdaweb.com) its earlier comments based on the 12/27/2023 revised draft.

Finally, the Mintz law firm [writes](https://www.regulations.gov/comment/FDA-2023-D-4177-0038?ref=fdaweb.com) “to address what appears to be FDA’s approach to preservative-free ophthalmic products generally and, more specifically, the use of multidose containers for preservative-free ophthalmic drug products. We are concerned that the guidance reflects a prejudice against all multidose preservative-free presentations of ophthalmic products.” The letter contains Mintz’ recommendations to improve the 2023 draft.