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- MedTech firms grow more comfortable with FDA's Quality Management System Regulation amid inspection concernsAt The MedTech Conference in Boston, a senior industry executive reported that the medtech sector is gradually accepting the new Quality Management System Regulation (QMSR) despite early worries.…
- FDA issues warning letters to drug makers over CGMP lapses and highlights patient rep ties to industry-backed groupsThe FDA has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practice requirements, citing problems with ensuring product sterility and meeting sp…