FDA clears an Ortho Development 510(k) for its Trivicta Hip System, a triple-taper femoral stem that is intended to facilitate an optimal fit within t...
Johnson & Johnsons Medos International Sarl device unit recalls its Cerebase DA Guide Sheath after receiving an increase in complaints about fractures...
Federal Register notice: FDA corrects a 12/18 notice that announced the withdrawal of a Chartwell RX Sciences NDA for Flowtuss.
Federal Register notice: FDA makes available a draft guidance entitled E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and...
A Science investigative report looks at issues found by FDA in a laboratory analysis of results from trials of Cassavas potential Alzheimers drug simu...
Republican Sen. Bill Cassidy asks interested parties to submit their ideas for congressional action to reform the regulation of clinical tests.
FDA approves a Madrigal Pharmaceuticals NDA for Rezdiffra (resmetirom) for treating adults with noncirrhotic non-alcoholic steatohepatitis.
FDA publishes a draft ICH guidance on post-marketing individual case study reporting.
