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Pharma Import Alert: FDA Working Towards Consistency, Better Decision Making

 
• By Sarah Karlin-Smith

FDA’s broad reorganization may not create the same super-specialization for the import staff that is coming to other parts of the agency, but a process overhaul appears on its way regardless.

FDA is taking steps that could provide some greater predictability for pharmaceutical companies importing drugs or drug ingredients into to the U.S, a new agency action plan indicates.

A risk-based imports entry review strategy for pharmaceutical products will be established and implemented during the first quarter of fiscal year 2015, which began Oct. 1.

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