This article was originally published in SRA
US FDA criticised for failing to adequately inspect foreign sites
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Congressional oversight agency urges FDA to make better use of foreign offices with more effective performance measures and staffing goals; GAO notes agency’s progress towards risk-based inspections – and its plan to revisit every site at least once every five years.
Japan’s Sawai was cautioned by one analyst earlier this year that it lacked sufficient excess production capacity to handle the sharp expansion in demand for its products. Now the company has announced plans to build a new solid dosage form facility.
Latest EU MDR notified body designation brings total in Italy to six, the same as Germany.