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CBER launches a new Web page on its approach to using AI/ML in regulatory oversight of products it regulates.[ Price : $8.95]
FDA clears a Fujifilm Healthcare Americas 510(k) for CAD EYE, an artificial intelligence detection system for endoscopic imaging.[ Price : $8.95]
FDA approves an Idorsia NDA for Tryvio (aprocitentan) for treating hypertension in combination with other antihypertensive drugs i...[ Price : $8.95]
Federal Register notice: FDA proposes to establish criteria for the lists of drug products or drug categories that present demonst...[ Price : $8.95]
FDA approves Johnson & Johnsons Edurant PED (rilpivirine) for treating HIV-1 in combination with other antiretroviral therapies in...[ Price : $8.95]
FDA asks the Ophthalmic Devices Panel to discuss safety and other issues related to the Balance Ophthalmics FSYX ocular pump to lo...[ Price : $8.95]
FDA reports the key themes that emerged from a 3/2023 virtual meeting with patients and caregivers on long Covid.