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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 020592Orig1s040s041 RISK ASSESSMENT and RISK MITIGATION REVIEW(S) REMS MEMO NEW APPROVAL TEMPLATE October 21, 2009, Risk Evaluation and
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Reviews - AccessData FDA is a system designed to collect and analyze information about medical devices.
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Information such as adverse events, device malfunctions, and corrections or removals must be reported on reviews.
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