[ Price : $8.95]
FDA publishes a draft guidance on third-party review of 510(k)s and EUAs.[ Price : $8.95]
FDA says CDRH has begun issuing several types of electronic export documents for medical devices.[ Price : $8.95]
FDA warns Ringwood, NJ-based Inopak about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA places a clinical hold on Iovance Biotherapeutics IOV-LUN-202 clinical trial, which is assessing LN-145 tumor infiltrating lym...[ Price : $8.95]
FDA Webview summarizes the Federal Register notices published during our holiday break.[ Price : $8.95]
A KFF Health News report on a year-long investigation into the FDA 510(k) medical device clearance pathway finds significant flaws...[ Price : $8.95]
FDA warns Commerce, CA-based Colonial Dames Company about repeat CGMP violations in its manufacture of misbranded and unapproved d...[ Price : $8.95]
FDA warns Solna, Sweden-based Sonesta Medical about Quality System violations in its manufacturing of three medical devices.