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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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Inspection Delays Remain For Novel Approvals By US FDA; Will Quality Office Help?

Final assessment of the PDUFA V new drug review 'Program' flagged inspection delays as a continued sticking point for on-time approvals. US FDA says consolidation of manufacturing oversight under the agency’s new quality office will help.

FDA Wants Better PDUFA Fees-Goals Alignment, Predictability

While industry wants better integration of the patient perspective into US drug development and regulatory decision-making and an enhancement of the scientific expertise, processes and tools regulators use, the FDA said it would like to see greater alignment of the fee structure with its public health goals and improved predictability of the dollar amounts under the next round of the Prescription Drug User Fee Act – PDUFA VI – according to the minutes from the first meeting to negotiate terms.

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.

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