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FDA says it is launching a Digital Health Center of Excellence within CDRH.[ Price : $8.95]
FDA grants Spineology Inc. a de novo marketing authorization for its OptiMesh Expandable Interbody Fusion System.[ Price : $8.95]
FDA adds content to a question-and-answer appendix in its guidance entitled Conduct of Clinical Trials of Medical Products during ...[ Price : $8.95]
Years of complaints about the adequacy of CDRH device labeling requirements are echoed in a new raft of complaints about the safet...[ Price : $8.95]
Federal Register notice: FDA makes available a replacement final guidance entitled Investigational Covid-19 Convalescent Plasma.[ Price : $8.95]
Federal Register notice: FDA withdraws a May-issued final guidance entitled Investigational COVID19 Convalescent Plasma because th...[ Price : $8.95]
Former FDA commissioner Scott Gottlieb criticizes a recent move by HHS to redirect its authority to prevent FDA and other health a...[ Price : $8.95]
FDA approves a Simplify Medical PMA for its Simplify Artificial Disc for one-level disc replacement indications.