其 他 安 全 警 示
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| The United States: Public safety notification on amniotic fluid eyedrops (English only) |
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The US Food and Drug Administration (FDA) announces that manufacturers are marketing and distributing amniotic fluid eyedrops to treat, mitigate, or cure diseases or conditions such as dry eye disease without the required premarket review and approval, raising potential significant safety concerns.
As a general matter, amniotic fluid eyedrops used to treat diseases and conditions in humans are regulated as drugs and biological products and are subject to premarket review and approval requirements. There are currently no FDA-approved amniotic fluid eyedrops to treat, mitigate or cure eye diseases or conditions, and in order for a health care practitioner to offer these products to patients, there must be an investigational new drug application in effect. In addition, as these products are not FDA-approved, the agency does not have information about their manufacture, and there are no assurances that the products are safe and effective for any disease or condition.
FDA has taken steps to notify manufacturers marketing amniotic fluid eyedrops regulated as drugs and biological products without FDA review or approval. The agency issued two untitled letters in late 2022 to manufacturers of these products (product name: Regener-Eyes® Ophthalmic Solution, StimulEyes) that are available on the FDA website.
Please refer to the following website in FDA for details:
http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-amniotic-fluid-eyedrops
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Tuesday, Apr 11, 2023
Issued at HKT 13:00
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