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Eye Drop Manufacturers Get Advice On Seeing Quality Clearly In US FDA Draft Guidance

 
• By Malcolm Spicer

Need for guidance shown not only in recalls over past year of OTC eye drops due to bacterial contaminants found in products and insufficient sterility practices in facilities but also in warning letters sent in 2022 and 2023 to firms manufacturing Rx and OTC ophthalmic drugs.

• Source: Shutterstock

The US Food and Drug Administration is providing drug firms with a draft guidance on quality for eye drops and other topical ophthalmic products following a jump the past two years in contamination problems.

The need for the guidance was shown not only in recalls over the past year of OTC eye drops due...

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