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UK lawmakers on Friday failed to approve an orderly withdrawal from the European Union, leaving drugmakers and regulators scrambling to make sense of the chaos. Read More
FDA Commissioner Scott Gottlieb and two of his top aides took to the internet Friday to urge drug sponsors to continue treatment for especially needy clinical trial patients after their studies end and before the new treatment is officially approved. Read More
EU regulators flagged 18 percent of inspected biologics and nine percent of inspected drugs for scientific or regulatory problems in the two decades since European regulators began inspecting drugs and medicines, the European Medicines Agency said in a report issued Thursday. Read More
New York’s Attorney General Letitia James on Thursday joined the opioid fray accusing drugmakers and distributors—including Purdue Pharma and its owners, the Sackler family—of unleashing a “plague” that has killed thousands. Read More
It was a lovefest for outgoing FDA Commissioner Scott Gottlieb on Thursday as he testified before the Senate Committee on Appropriations on the FDA’s budget request for fiscal 2020. Read More