FDA warns Chelmsford, ME-based Zoll Medical about Quality System and Medical Device Reporting violations in its manufacturing of several medical devic...
FDA warns Canadas Sante Manufacturing about CGMP issues found in an agency review of requested records detailing the firms manufacturing of over-the-c...
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...
Eli Lilly reports positive Phase 3 results for its BTK inhibitor Jaypirca (pirtobrutinib) in combination with venetoclax and rituximab.
Significant operational hurdles remain before FDA's Plausible Mechanism Framework can be broadly implemented, according to a commentary published by S...
