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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 201655Orig1s000 REMS Initial REMS Approval: 12/2011 NDA 201655 ? ER (Hydrochloride Extended-Release Tablets) Opioid Analgesic END Pharmaceuticals
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What is risk evaluation and mitigation?
Risk evaluation and mitigation is a process that involves identifying, assessing, and implementing measures to reduce or eliminate potential risks and their impact on individuals or organizations.
Who is required to file risk evaluation and mitigation?
The requirement to file risk evaluation and mitigation depends on the specific regulations or policies in place. Generally, it may be required by regulatory agencies, government bodies, or organizations implementing risk management strategies.
How to fill out risk evaluation and mitigation?
Filling out a risk evaluation and mitigation form typically involves gathering relevant information, assessing risks, and implementing appropriate mitigation measures. The specific process may vary depending on the regulations or guidelines provided.
What is the purpose of risk evaluation and mitigation?
The purpose of risk evaluation and mitigation is to identify potential risks, assess their likelihood and potential impact, and implement measures to reduce or eliminate these risks. This helps to safeguard individuals, organizations, or the public from harm or negative consequences.
What information must be reported on risk evaluation and mitigation?
The information reported on risk evaluation and mitigation forms may vary depending on the specific requirements or guidelines. Generally, it includes details about the identified risks, their assessment, proposed mitigation measures, and any relevant supporting documentation.
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