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GDUFA III: First-Cycle Approval, Priority Assessment Improvements Are Early Priorities

Executive Summary

Both issues have been the subject of questions and criticism as the FDA and industry attempt to boost generic competition.

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GDUFA III: US FDA Says Generic Drug Supplement Volume Could Require More Resources

Will the growing workload cause GDUFA fees to increase or prompt other changes?

GDUFA III Calculation Faces Rising Staff Costs

After dialing back the inflation adjustment in GDUFA II, FDA’s ANDA review program now faces rising personnel costs, in contrast to the agency overall, suggesting that GDUFA III might need a more tailored formula.

Generic Drug User Fee Projections Complicated By Shifting Personnel Costs

After dialing back the inflation adjustment in GDUFA II, FDA’s ANDA review program now faces rising personnel costs, in contrast to the agency overall, suggesting that GDUFA III might need a more tailored formula.

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