Device Companies and Disease Management
For most medical device and supply companies, the changes in the marketplace over the past decade were largely sales and marketing issues. But that’s too limited a point of view with which to address the changes managed care will bring.
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The deal is part of Medtronic's ongoing strategy to revive its diabetes business with technology that simplifies insulin delivery.
In advisory committee briefing documents, agency also says critical quality attributes of the graft-versus-host disease treatment do not show a relationship with clinical potency and may not ensure control of clinical effectiveness of individual drug product lots.
International Pharmaceutical Excipients Council of the Americas supports the maximum daily exposure limit but suggests FDA retain potency limit field until it finishes adding MDE information to avoid causing confusion.