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.
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100% User Fees For US FDA? Trump Budget Revives Important Issue For Industry – But Not This Year
Trump Administration’s surprising call for increased user fees probably won’t have much impact on pending reauthorization process, but it does put on the table an important question for the biopharma industry to consider for the long term: should FDA be fully funded by user fees?
PDUFA V 'Program' First-Cycle Approval Rates Significantly Higher For All Applications
Success of review model for new molecular entities and novel biologics should bolster US FDA and industry's stance that Congress reauthorize the user fee program without tinkering with the negotiated agreement, which retains the 'Program' but builds in more flexibility.
PDUFA VI: A Machine To Speed R&D Time, Cut Costs
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.