FDA approves a GE Healthcare PMA for its End-tidal (Et) Control software for general anesthesia delivery on its Aisys CS2Anesthesia Delivery System.
A new FDA whitepaper outlines the agencys plans to advance a framework to objectively rate pharmaceutical manufacturing sites Quality Management Matur...
FDA grants priority review for Sanofi and Regenerons sBLA for a new Dupixent indication.
FDA warns Monterey, CA-based NDAL Mfg. that it is manufacturing unapproved new drugs with CGMP violations.
AstraZeneca and Janssen comment on an FDA draft guidance on immunogenicity information in drug product labeling.
FDA says the availability of duodenoscopes that are fully disposable or have disposable components should lead to hospitals and endoscopy facilities m...
Seven senators ask the HHS Inspector General to look into McKinsey & Company's conflicts of interest while working with FDA and the agencys contractin...
CDERs Office of Surveillance and Epidemiology (OSE) discusses new and enhanced activities in postmarketing safety reviews.