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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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Safety and efficacy refer to the ability of a product to produce the desired effect while minimizing the risk of harmful side effects.
Manufacturers or sponsors of products are typically required to file safety and efficacy data with regulatory agencies.
Safety and efficacy data is usually filled out using standardized forms provided by regulatory agencies.
The purpose of safety and efficacy data is to demonstrate that a product is safe and effective for its intended use.
Information on the formulation, manufacturing process, clinical studies, and adverse reactions must be reported on safety and efficacy data.
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