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Pediatric Exclusivity and the Regulatory Authority of the FDA

19:00 EST 7 Nov 2017 | JAMA

This Viewpoint uses the legal dispute between Amgen and the US Food and Drug Administration (FDA) regarding the FDA’s denial of market exclusivity for cinacalcet to discuss the FDA policy granting 6 months of market exclusivity as an incentive for manufacturers to conduct efficacy and safety studies in child populations.

Original Article: Pediatric Exclusivity and the Regulatory Authority of the FDA

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