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

 
• By Derrick Gingery

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

PriorityFastLane
GDUFA III negotiations include discussions of the pre-submission facility correspondence program, a prerequisite for a priority assessment. • Source: Shutterstock

Increasing first-cycle approvals and improving the priority assessment pathway have emerged as initial priorities for the US Food and Drug Administration and industry in generic drug user fee reauthorization negotiations.

Agency and industry representatives are looking for changes to different areas of the generic drugs program, but the shared goal...

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