What does REMS stand for in relation to FDA requirements for drug manufacturers?

REMS stands for Risk Evaluation and Mitigation Strategy. This is a program required by the FDA for certain medications that have been identified to carry specific risks. The purpose of REMS is to ensure that the benefits of a drug outweigh its risks, particularly for medications that have severe side effects or risk factors that could lead to serious adverse reactions.

A REMS may include various components such as requirements for healthcare providers, patients, or pharmacies to ensure safe use of the medication. For example, a REMS may require healthcare providers to be certified to prescribe a medication or mandate that patients be enrolled in a registry to monitor their health.

This system is crucial for maintaining patient safety while allowing access to necessary therapies that may have potential risks. The other options do not correctly capture the meaning or function of REMS, as they utilize terms or structures that do not accurately reflect the established terminology and framework as defined by the FDA.