The US Food and Drug Administration (FDA) recently issued a revised draft guidance for topical ophthalmic drugs recommending that manufacturers follow certain microbial testing guidelines to ensure that products remain sterile throughout the drug’s shelf life. This action responds to consumer injuries and deaths from microbially contaminated ophthalmic drug products as well as recent recalls. The scope of the guidance has also been expanded to include topical ophthalmics made at outsourcing facilities.
The guidance discusses quality considerations for ophthalmic gels, ointments, creams, and liquid formulations intended for topical delivery in and around the eye, and replaces a draft issued in October 2023. (RELATED: FDA issues guidance on assessing quality of topical ophthalmic drugs, Regulatory Focus 16 October 2023)…
