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Pediatric Studies: Must Sponsors Meet Every Detail Of US FDA Request To Get Exclusivity?

 
• By Brenda Sandburg

In suit against FDA, Amgen argues it provided sufficient data to obtain exclusivity for Sensipar but agency says too few patients were included in one study; court ruled against FDA in similar 2001 dispute.

court house

How much wiggle room do sponsors have when the US FDA asks them to conduct pediatric studies? The question is again at issue in Amgen Inc.'s suit against FDA objecting to the agency's denial of pediatric exclusivity for Sensipar (cinacalcet).

The complaint specifically addresses when studies "fairly respond" to the agency's written request for them. FDA contends that...

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