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The Quality Lowdown: EU/Japan MRA, Field Alerts, Akorn, New Pfizer Plant, And The Answer Is Continuous Manufacturing

 
• By Bowman Cox

Japan and EU expand drug inspection agreement while rebuking Trump on trade; Pfizer invests tax cut in modular plant; FDA commissioner sells continuous manufacturing.

conveyer
FDA conveys the benefits of continuous manufacturing

Japan and the European Union showed the US what a mutually beneficial trade deal can look like, and in the process expanded their 14-year-old mutual recognition agreement for drug inspections a little over a year after the incoming Trump administration went along with the landmark US/EU MRA that had been queued up by the Obama administration’s FDA.

Meanwhile, FDA has advised pharmaceutical companies that it would like them to issue additional types of field alert reports to...

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