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FDA warns Canadas Sante Manufacturing about CGMP issues found in an agency review of requested records detailing the firms manufac...[ Price : $8.95]
North Dakota State University economist Raymond March faults the way in which FDA provides risk management guidance to regulated c...[ Price : $8.95]
A cancer center precision medicine expert calls on FDA to require labeling changes for some non-small cell lung cancer immune chec...[ Price : $8.95]
Draeger expands a 10/2024 device correction (Class 1 recall) to include additional Atlan A350 and A350XL anesthesia workstations u...[ Price : $8.95]
FDA sends a Warning Letter to Greek contract manufacturer Pharmathen International citing significant GMP violations at its steril...[ Price : $8.95]
Eli Lilly reports positive Phase 3 results for its BTK inhibitor Jaypirca (pirtobrutinib) in combination with venetoclax and ritux...[ Price : $8.95]
Significant operational hurdles remain before FDA's Plausible Mechanism Framework can be broadly implemented, according to a comme...[ Price : $8.95]
FDA increases scrutiny of telehealth companies marketing compounded drugs, warning that some firms are making false or misleading ...