On Dec. 27, 2023, the FDA also revised the draft guidance for industry, Quality Considerations for Topical Ophthalmic Drug Products, to articulate important changes, including added information about product sterility and preservative use, as well as a clarified scope regarding drug products that are not marketed under section 505G of the Federal Food, Drug and Cosmetic Act, or pursuant to an FDA approval or licensure. To read the revised guidance and for more information on how to submit comments to the docket, visit the guidance page.