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FDA Staff ‘Literally’ Up At Night Deciding 3-Year Exclusivity Requests

 
• By Brenda Sandburg

More sponsors are submitting applications around the same time requiring the agency to make complicated decisions about exclusivity and whether approval of subsequent applications is barred, FDA attorney says.

Complex decision
FDA is making complicated decisions about awarding three-year exclusivity to drug products • Source: Shutterstock

Among the US Food and Drug Administration’s enormous workload, one task is consuming much more of its time: determining if products qualify for three-year exclusivity when the sponsor conducts a new clinical investigation.

Nisha Shah, senior regulatory counsel at FDA’s Center for Drug Evaluation and Research, described the difficulty in making these exclusivity decisions at the Food and Drug Law

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