FDA Mutual Reliance With EU On Inspections Is Slow Going

 
• By Derrick Gingery

FDA still does over 40% of its inspections in Europe even as it acknowledges it must spend the money elsewhere.

FDA wants to expand its information sharing with the European Medicines Agency, but is not ready to say that it could rely only on foreign data to approve manufacturing facilities.

By using EMA inspection reports to determine whether a facility is acceptable, FDA stands to save millions of dollars, which...

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