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NDA 20-687 Tablets 200 mg Danco Laboratories LLC PO Box 4816 New York NY 10185 RISK EVALUATION AND MITIGATION STRATEGY REMS I. B. The following materials are part of the REMS and are appended i. Prescriber s Agreement. ii. Patient Agreement. Reference ID 2957855 2. will be dispensed only in certain health care settings specifically clinics medical offices and hospitals. B. To minimize the risk of serious complicatio...
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What is sample rems?
Sample REMS stands for Risk Evaluation and Mitigation Strategy. It is a program implemented by the FDA to ensure the safe use of certain medications with known safety risks.
Who is required to file sample rems?
The pharmaceutical companies who market medications with significant safety risks are required to file Sample REMS.
How to fill out sample rems?
To fill out Sample REMS, pharmaceutical companies need to provide comprehensive information about the medication, its potential risks, and the strategies to mitigate those risks.
What is the purpose of sample rems?
The purpose of Sample REMS is to minimize the risks associated with certain medications, protect patients from potential harm, and ensure safe and effective medication use.
What information must be reported on sample rems?
Sample REMS must include information such as the medication's known safety risks, specific patient populations that may be at higher risk, strategies to minimize risks, and post-marketing surveillance plans.
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