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Fluorescein Angiography:Preventing and Responding to Complications Anne M. Make, RN, PhD COMIC Patient Safety ManagerPURPOSE OF RISK MANAGEMENT RECOMMENDATIONSOMIC regularly analyzes its claims experience
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Safety and efficacy refers to the measures taken to ensure that a product or treatment is both safe and effective for its intended use.
Companies or individuals who are seeking approval for a new product or treatment are required to file safety and efficacy information.
Safety and efficacy information is typically filled out by providing data from clinical trials, studies, and research that demonstrate the product's safety and effectiveness.
The purpose of safety and efficacy information is to provide regulatory agencies with evidence that a product or treatment is safe and effective for use.
Information that must be reported includes data from clinical trials, studies on the product's safety profile, and any adverse effects observed.
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