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FDA Refines Premarket, GMP Paths For Combination Products

This article was originally published in The Silver Sheet

Executive Summary

COMBINATION PRODUCTS ARE FOCUS OF INTENSE ACTIVITY at FDA, as the Office of Combination Products strives to finalize new regulations and guidances clarifying policies for premarket review and manufacturing quality control. FDA staff promise to take industry concerns into account in final rule concerning "primary mode of action," which will play a crucial role in future assignments of combos to a lead center within the agency. Longstanding questions about the applicability of QS regs and drug cGMPs to combos are answered in a recent draft guidance. For those preparing to enter the combination product world, the stories of firms that have already navigated FDA premarket and compliance channels offer a glimpse of what to expect

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