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Massachusetts-based Fresenius Medical Care North America has issued two voluntary recalls of a concentrate used in dialysis machines over fears of bacterial contamination, the FDA said Thursday. Read More
Drugmakers are asking the FDA to create separate submission requirements for NDAs, ANDAs and BLAs to demonstrate analytical procedures and methods-validation data is adequate to support the drug and biologic products. Read More
Another compounding pharmacy has received an FDA warning for actions that occurred prior to passage of a new law that boosted the agency’s authority over such facilities. Read More
German drugmaker Sanum-Kehlbeck has been cited for using the same equipment to produce penicillin and non-penicillin products, a situation that could lead to serious allergenic reactions in some patients. Read More
International and U.S. authorities this week seized more than $31 million in potentially counterfeit and dangerous drugs and shut down more than 10,600 websites for peddling unapproved and substandard pharmaceuticals in the third annual international sweep of its kind. Read More
The FDA has issued a warning letter to Sanum-Kehlbeck for using the same equipment to produce penicillin and non-penicillin products and other quality violations. Read More
Beleaguered Indian generics maker Wockhardt is recalling 109,744 bottles of the hypertension drug metoprolol due to problems with how the product dissolves in the body. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
Canadian drug regulators have temporarily banned Biolyse Pharma from making and selling its cancer-fighting agent paclitaxel after a series of inspections at the firm’s St. Catharines, Ontario, facility uncovered serious manufacturing problems. Read More
The FDA slapped Blue Ridge Pharmacy and Compounding Center with a warning letter for compounding products without a prescription and poor conditions for aseptic processing, another sign that the agency doesn’t plan to let up on large compounders. Read More
European and U.S. regulators have made strides towards mutual recognition of quality inspections so that companies being inspected by one regulator would not have to face an inspection by the other, but setbacks still remain, a top European regulatory official said. Read More