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Spending User Fees: Biomarker Research, Drug-Device Combos?

This article was originally published in Scrip

Executive Summary

Even though the technical negotiations between the FDA and representatives from the biopharmaceutical industry are just getting underway this month in earnest for the sixth round of the Prescription Drug User Fee Act (PDUFA VI), some regulators and drug makers already have their eyes set on how the money should be spent, or at least, some of it.

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