FDA says CDRH has begun issuing several types of electronic export documents for medical devices.
FDA warns Ringwood, NJ-based Inopak about CGMP violations in its production of finished drugs.
FDA places a clinical hold on Iovance Biotherapeutics IOV-LUN-202 clinical trial, which is assessing LN-145 tumor infiltrating lymphocyte therapy in n...
FDA Webview summarizes the Federal Register notices published during our holiday break.
A KFF Health News report on a year-long investigation into the FDA 510(k) medical device clearance pathway finds significant flaws that have injured p...
FDA warns Commerce, CA-based Colonial Dames Company about repeat CGMP violations in its manufacture of misbranded and unapproved drugs.
FDA warns Solna, Sweden-based Sonesta Medical about Quality System violations in its manufacturing of three medical devices.
FDA publishes a guidance with recommendations on using digital health technologies for remote data acquisition.
