The US Food and Drug Administration (FDA) issued new draft guidance recommending a battery of studies that manufacturers should use to assess the quality of topical ophthalmic drugs.
The assessment includes visible particle studies, extractables and leachables studies, container closure system studies, as well as studies to assess impurities and degradation products.
FDA’s guidance was issued is a response to multiple recent incidents of contaminated eye drops, including an April 2023 warning letter to Pharmedica for making eye drops that could potentially cause blindness. In February 2023, FDA also notified consumers to stop using sterile eye drops made in India from Global Pharmaceutical Healthcare because of microbial contamination (RELATED: FDA warns Pharmedica over contamination controls for sterile eye drops, Regulatory Focus, 16 May 2023).
