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BLOG: Outsider’s view of the FDA approval process
Last week I had the unique opportunity to present before the FDA Ophthalmic Devices Panel the clinical results and experience with the ReSure ocular sealant proposed for approval for sealing leaking cataract wounds. Some background: When a company’s first-in-class drug or device seeks approval from the U.S. Food and Drug Administration, the FDA works with the company, called the “sponsor,” to design a trial to determine its safety and effectiveness. Before approval, a panel of experts, independent from the FDA, is convened in Washington to hear both the FDA's interpretation of (Read more...)