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B:8.75 in T:8.5 in S:8 in REMS Prescriber Enrollment Form All prescribers must be certified to prescribe (). To become certified the prescriber must: 1. Complete the Prescriber Enrollment Form, which

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What is rems - rems?

REMS (Risk Evaluation and Mitigation Strategy) is a program to manage known or potential risks associated with a drug product.

Who is required to file rems - rems?

The manufacturer of the drug product is required to file a REMS program with the FDA.

How to fill out rems - rems?

To fill out a REMS program, the manufacturer must assess the risks of the drug product and implement strategies to mitigate those risks.

What is the purpose of rems - rems?

The purpose of REMS is to ensure the safe use of certain drug products with known risks.

What information must be reported on rems - rems?

Information on the risks associated with the drug product and the strategies implemented to mitigate those risks must be reported on REMS.