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CENTER FOR DRUG EVALUATION ANDRESEARCHAPPLICATION NUMBER:212102Orig1s000REMSRISK EVALUATION AND MITIGATION STRATEGY (REMS) DocumentFINTEPLA () REMS Program I. Administrative InformationApplication

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What is rems program?

REMS stands for Risk Evaluation and Mitigation Strategies, which is a program required by the FDA for certain medications to ensure that their benefits outweigh the risks.

Who is required to file rems program?

Pharmaceutical manufacturers of specific medications that require a REMS program are obligated to file it.

How to fill out rems program?

To fill out a REMS program, manufacturers must submit a detailed plan outlining risk management strategies, including communication, education, and monitoring.

What is the purpose of rems program?

The purpose of REMS is to ensure that the benefits of a drug outweigh its risks, to protect public health, and to ensure safe usage.

What information must be reported on rems program?

Information required on a REMS program includes risk assessment data, educational materials, monitoring protocols, and compliance measures.

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