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The systemic management of cutaneous dermatomyositis: results of a stepwise strategy

Thatte AS, Billingsley MM, Weissman D, Melamed JR, Mitchell MJ

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FDAs review of a PMA submission is a four-step process that consists of: Administrative and limited scientific review to determine completeness of the application In-depth scientific, regulatory, and quality management system review Panel review by an appropriate advisory committee Final deliberations, documentation, and notification of the FDAs decision FDA will complete its review of the PMA application and advisory committees report and issue a decision within 180 days of the PMA filing