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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Arbor Center for EyeCare did not submit an investigational new drug (IND) application before beginning its clinical trial, the US Food and Drug Administration said. The agency posted the warning letter on 29 November.

The FDA inspected the Arbor Center’s clinical site during April as a part of the agency’s Bioresearch Monitoring Program, which looks

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