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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207620Orig1s000 RISK ASSESSMENT and RISK MITIGATION REVIEW(S) Department of Health and Human Services Public Health Service Food and Drug
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Final risk evaluation is a comprehensive assessment of potential risks associated with a specific substance or product.
Companies or individuals involved in the production, distribution, or use of the substance or product are required to file the final risk evaluation.
Final risk evaluation can be completed by providing detailed information about the substance or product, its potential risks, and any safety measures in place.
The purpose of final risk evaluation is to identify and mitigate potential risks associated with a substance or product to protect human health and the environment.
Information such as chemical composition, usage, exposure levels, potential hazards, and risk management measures must be reported on the final risk evaluation.
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