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Safety and efficacy refer to the assessment of how safe a product is for consumers and how well it performs its intended purpose, commonly used in the context of pharmaceuticals and medical devices.
Manufacturers and sponsors of pharmaceutical products and medical devices are typically required to file safety and efficacy information with regulatory authorities.
To fill out safety and efficacy information, one must provide detailed data on clinical trials, adverse effects, and performance metrics, following specific guidelines set by regulatory agencies.
The purpose of safety and efficacy documentation is to ensure that products are safe for human use and effective for their intended purposes, thereby protecting public health.
The information that must be reported includes clinical trial results, adverse events, dosage information, and the benefits and risks associated with the product.
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