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Federal State Autonomous Educational Institution of Higher Education I.M. Techno First Moscow State Medical University Ministry of Health of the Russian Federation (Techno University)\”Approved\” Academic
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Form efficacy and safety refers to the documentation submitted to demonstrate the effectiveness and safety of a product, typically in the context of pharmaceuticals, medical devices, or other health-related products.
Manufacturers, sponsors, or applicants of health-related products that seek regulatory approval or marketing authorization are required to file form efficacy and safety.
To fill out the form efficacy and safety, the applicant must provide detailed data on the product's clinical trials, including methodology, results, safety profiles, and any adverse effects observed during testing.
The purpose of form efficacy and safety is to ensure that health-related products are both effective for their intended use and safe for consumers before they reach the market.
Information that must be reported includes clinical trial results, product labeling details, adverse event reports, and any other relevant safety data.
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