FDA Warns Eye Care Company Conducting Unapproved Clinical Trial Of Drug-Device Product
The FDA sent a warning letter to Arbor Center for EyeCare for failing to submit an IND before beginning a trial of a novel drug-device combination product.
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Ophthalmic Dispensers Recommended Class I Designation By FDA Panel
The FDA’s Ophthalmic Devices Panel approved a Class I designation for ophthalmic dispensers, which were reclassified from drugs to devices after the Genus v. FDA decision.
News We’re Watching: Two Join Illumina Board, FDA Plans Health Equity Meeting, Pre-Eclampsia Test Cleared
This week, Illumina’s board added two independent members; the VA and the FDA agreed to collaborate on supply chain issues; and Think Surgical, Thermo Fisher Scientific and Blue Earth all landed FDA clearances.
Joint AI/ML Risk Management Guidance Brings FDA Standard To UK
A collaborative document by a US and British organizations brings FDA-approved AI/ML risk management standards to the UK.