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The FDA is pressing a GlaxoSmithKline subsidiary to make a hard choice about operations at a U.K. plant: either decontaminate the whole facility to address repeated problems with penicillin contamination or restrict production to penicillin. Read More
Spanish regulators are recommending EU officials suspend a manufacturing certificate from a Chinese API maker over repeated issues at its plant. Read More
The FDA is faulting a clinical investigator for neglecting to follow the established procedures for a trial testing a new investigational drug. Read More