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FDAMA |
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The court decision picked up on plaintiffs' argument that the FDAMA and the BPCA set up voluntary programs for pediatric studies of drugs and incentives for those studies when drugs were not explicitly marketed for children's use. This incentive was included in FDAMA to encourage pharmaceutical companies to conduct studies of drugs for which additional pediatric information may produce health benefits in children. Under certain circumstances FDAMA allows for a PMA Sponsor to present disputed scientific issues to an independent Medical Devices Dispute Resolution Panel ("MDDRP"). |
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