FDA releases four cancer clinical trial eligibility criteria guidances for patients with hiv, hepatitis b or c virus infections, organ dysfunction, an...
FDA approves an Allergan supplemental BLA for an expanded use for Botox (onabotulinumtoxinA) treating spasticity in pediatric patients.
FDA clears a Mim Software 510(k) for its deep learning auto-contouring software, Contour ProtgAI.
FDA makes available a draft guidance entitled Select Updates for Peripheral Vascular Atherectomy Devices -Premarket Notification [510(k)] Submissions....
Federal Register notice: FDA seeks consumer organizations interested in participating in selecting voting or nonvoting consumer representatives to ser...
Federal Register notice: FDA seeks comments on a new information collection for data to support cross-center collaboration for social behavioral scien...
Federal Register notice: FDA seeks comments on a new information collection entitled Examination of Secondary Claim Disclosures and Biosimilar Disclos...
Two stakeholders comment to FDA on the agencys public workshop on the evolution of artificial intelligence in radiological imaging.