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The FDA has faulted two compounders for neglecting to apply quality controls to the production of their sterile drugs, pummeling one of the compounders with 13 citations. Read More
Three clinical investigators were cited for deviating from their investigational plans recently by the FDA for a litany of different reasons. Read More
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 else restrict production to penicillin. Read More
The data integrity issues most likely to lead to a delay in FDA marketing approval for new drugs include poor quality control for data entry, systemic errors at clinical study sites — such as enrolling ineligible patients — and database changes made after an initial database lock and study unblinding. Read More