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APPENDICES APPENDIX I- RISK EVALUATION & MITIGATION STRATEGY (REMS) Title: Product Name: Sponsor: Date: Risk Evaluation & Mitigation Strategy (REMS): Support, Help and Resources for Epilepsy (SHARE)
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What is rems - food and?
REMS stands for Risk Evaluation and Mitigation Strategies. It is a program implemented by the Food and Drug Administration (FDA) to ensure the safe use of certain medications.
Who is required to file rems - food and?
Manufacturers of medications that are determined to have significant risks or requirements for safe use are required to file REMS with the FDA.
How to fill out rems - food and?
To fill out REMS, manufacturers need to develop and submit a comprehensive plan that includes risk assessment, education programs, monitoring strategies, and communication plans to the FDA.
What is the purpose of rems - food and?
The purpose of REMS is to ensure that the benefits of certain medications outweigh their risks by implementing additional measures to mitigate those risks and ensure their safe use.
What information must be reported on rems - food and?
REMS requires manufacturers to report information such as adverse events, medication errors, effectiveness of risk mitigation strategies, and any additional relevant data to the FDA.
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