Questions on Topical Ophthalmic Draft Guide

The Association for Accessible Medicines raises these concerns about an FDA draft guidance on quality considerations for topical ophthalmic drug products: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 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 its earlier comments based on the 12/27/2023 revised draft.

Finally, the Mintz law firm writes “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.