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Getting a Jump on PDUFA V: Fast Start on REMS, Patient Input – And Longer Reviews

This article was originally published in RPM Report

Executive Summary

The new Prescription Drug User Fee Act Program doesn’t take effect until October 1, but FDA has been getting moving on some key elements of the program since before the final negotiations began on Capitol Hill. FDA will need to move fast to meet the many policy deadlines set by the agreement negotiated with industry.

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