North Dakota State University economist Raymond March faults the way in which FDA provides risk management guidance to regulated companies.
A cancer center precision medicine expert calls on FDA to require labeling changes for some non-small cell lung cancer immune checkpoint inhibitors to...
Draeger expands a 10/2024 device correction (Class 1 recall) to include additional Atlan A350 and A350XL anesthesia workstations used in operating roo...
FDA sends a Warning Letter to Greek contract manufacturer Pharmathen International citing significant GMP violations at its sterile drug manufacturing...
A 6/18 advisory committee meeting is set to review Moderna's investigational mRNA influenza vaccine as the agency posts a briefing document revealing ...
FDA says there is an implementation delay for isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy modifications.
FDA warns Chelmsford, ME-based Zoll Medical about Quality System and Medical Device Reporting violations in its manufacturing of several medical devic...
A citizen petition urges FDA to impose an immediate moratorium on the use of gadolinium-based contrast agents in MRI scans.
