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Two more compounding pharmacies are in the FDA’s crosshairs, with one faulted for failing to maintain proper sterility while the other was accused of compounding without valid prescriptions. Read More
Despite the FDA approving more than 99 percent of expanded access requests and offering emergency access authorization, a Senate committee chairman introduced legislation Tuesday that prohibits the FDA from interfering in the prescribing of investigational drugs to terminally ill patients. Read More
French authorities want to ban marketing applications from an Indian manufacturing site after an inspection turned up a whopping 58 GMP violations. Read More
The FDA has fired off warning letters to two supplement makers over GMP concerns ranging from record handling to incomplete batch production records. Read More
As pharmacy benefit managers’ exclusion lists grow longer, drug developers hoping to avoid those lists must scramble to demonstrate clinical superiority and cost-effectiveness of their products, according to a new report. Read More