PDUFA VI: A Machine To Speed R&D Time, Cut Costs
Executive Summary
The biopharmaceutical industry is hoping the terms set under the negotiations with the FDA for the sixth round of the Prescription Drug User Fee Act will help reduce the time and money spent on developing medicines, allowing companies to get their products into the commercial setting quicker and maximize those therapies' potential.
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FDA Wants Better PDUFA Fees-Goals Alignment, Predictability
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Spending User Fees: Biomarker Research, Drug-Device Combos?
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.