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REMS  Food and Drug Administration  Fda  Form

REMS Food and Drug Administration Fda Form

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good afternoon my name is Cynthia Aceveda and I'm the director for the division of risk management it is my pleasure to be able to share with you the role of the division in the review of new drug biological and generic applications as well as post approval when safety concerns occur for products that may require a REMS I will be providing an overview of the REMS authorities and the agency's current thinking on ramps as described in guidance dr. Sheppard will join me in providing an overview of the vision of risk management's role in the review of the various applications both pre and post marketing the learning objectives for today's session include understand when the agency can require a REMS describe the types of changes that can be made to REMS identify all components of a complete run submission and describe the role of the division risk management and the lifecycle of Em's the agency has over 50 years of experience with risk management pro

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