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VIRUS
Safety and Efficacy of the Venice Vice
Venous Stent System (Venice Inc.) when
Used to Treat Clinically Significant
Chronic Nonmalignant Obstruction of
the Tibiofemoral Venous Segment
Protocol
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What is safety and efficacy of?
Safety and efficacy refer to the ability of a product to produce the desired effect while minimizing the risk of harmful side effects.
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Manufacturers or sponsors of products are typically required to file safety and efficacy data with regulatory agencies.
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Safety and efficacy data is usually filled out using standardized forms provided by regulatory agencies.
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The purpose of safety and efficacy data is to demonstrate that a product is safe and effective for its intended use.
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Information on the formulation, manufacturing process, clinical studies, and adverse reactions must be reported on safety and efficacy data.
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