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FDA adds four items to its online medical device cybersecurity page.[ Price : $8.95]
FDA says the benefits of NuInvasive titanium-based Precice devices continue to outweigh the known risks with updated labeling in p...[ Price : $8.95]
FDA clears an Immunexpress 510(k) for its SeptiCyte Rapid, a diagnostic aid for use in differentiating sepsis from infection-negat...[ Price : $8.95]
FDA issues a clinical hold for undisclosed reasons on an Ocugen IND intended to evaluate the companys Covid-19 vaccine candidate, ...[ Price : $8.95]
Stakeholders express concerns about an FDA decision in response to an appeals court ruling to reclassify some drugs as drug-led co...[ Price : $8.95]
FDA warns Invacare about QS violations found in inspections at three of its oxygen concentrator manufacturing facilities.[ Price : $8.95]
Two stakeholders make suggestions for changes to an FDA draft guidance on investigator responsibility for safety reporting for inv...[ Price : $8.95]
FDAs Antimicrobial Drugs Advisory Committee narrowly votes 13-10 to recommend an emergency use authorization for Mercks oral antiv...