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The FDA warned a partially defunct compounder for a multitude of quality violations such as using soap and water to clean parts of the production facility. Read More
European drugmakers praised a plan to move medicines regulation from a tripartite of directorates led by health and consumers to a single directorate, industry, saying it will reduce organizational silos. Read More
To avert drug shortages, Health Canada has partially lifted an import ban on products from three Indian manufacturing facilities that were barred from doing business in the country due to quality violations. Read More
Mylan recalled 15,966 bottles of the blood pressure drug metoprolol succinate tablets due to a product mix-up, the third recall in the past five months involving generic versions of AstraZeneca’s Toprol-XL. Read More
FDA investigators are finding unprecedented data integrity problems at contract and active pharmaceutical ingredient manufacturers, even after they have been audited by the firms that hired them, an FDA official said. Read More
Baxter International said it will launch its hemophilia drug Obizur in the next few months, after the FDA approved the product late Thursday. Read More
The Australian government has authorized an independent review of the country’s drug approval process to remove or streamline areas of unnecessary, duplicative or ineffective drug regulations. Read More
European drugmakers say they support recent EU efforts to fight counterfeiting, but would like to see some changes to a provision that aims to catch fake products as they move across member-state borders. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval following its recent meeting, including products to treat intolerance to sunlight, ovarian cancer, oestrogen deficiency and hemophilia B. Read More