FDA grants Elixir Medical a breakthrough device designation for its DynamX BTK System, an adaptive implant for use in treating narrowed or blocked ves...
Two SheppardMullin attorneys analyze a recent FDA draft guidance on informed consent and suggest steps that clinical trial sponsors, investigators, an...
FDA publishes a draft guidance on using non-interventional studies for drug and biological products to develop real-world evidence.
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...
