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FDA collaborates with academia to pursue patient-centric endpoints in glaucoma
FORT LAUDERDALE, Fla. — Patient preferences are a part of the regulatory science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products, Malvina B. Eydelman, MD, director of the FDA’s Division of Ophthalmic and Ear, Nose and Throat Devices, said at the American Glaucoma Society meeting. “Patient preferences is all about weighing the benefits and risks,” she said. “So for a low-benefit, high-risk device, the product may only get approved if significant evidence exists that at least a subset of (Read more...)