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An OpenTable, Single, Multi center Trial to Determine Safety and Efficacy of in the Prevention of Antibody Mediated rejection (AMR) in Sensitized Recipients of a Kidney Transplant from a Deceased
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What is safety and efficacy of?
Safety and efficacy refer to the measures taken to ensure that a product is safe and effective for its intended use.
Who is required to file safety and efficacy of?
Manufacturers or distributors of products are required to file safety and efficacy information.
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Safety and efficacy information can be filled out using a standardized form provided by the regulatory agency.
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The purpose of safety and efficacy information is to demonstrate that a product is safe and effective for its intended use.
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Information such as testing data, potential risks, and evidence of effectiveness must be reported on safety and efficacy forms.
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