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