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Two SheppardMullin attorneys analyze a recent FDA draft guidance on informed consent and suggest steps that clinical trial sponsor...[ Price : $8.95]
FDA publishes a draft guidance on using non-interventional studies for drug and biological products to develop real-world evidence...[ Price : $8.95]
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...