Aurobindo Pharma says FDA had 10 procedural observations from a pre-approval inspection at the firms new injectable facility in East Windsor, NJ.
FDA publishes an immediately effective guidance with its latest recommendations for submissions to support an emergency use authorization request for ...
FDA warns Amazon that its fulfillment service is distributing unapproved and misbranded new drugs labeled as energy-enhancing supplements or food.
FDA publishes a draft guidance on third-party review of 510(k)s and EUAs.
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.
