In which scenario might expedited review processes be employed?

Expedited review processes are designed to accelerate the availability of drugs that provide substantial benefits over existing options, particularly in situations where there is an unmet medical need or a significant improvement in treatment outcomes. When a treatment demonstrates that it offers a meaningful advance, such as improving efficacy, enhancing safety, or providing a new mechanism of action for a serious condition, regulatory agencies often prioritize its review. This is to ensure that patients can access more effective and innovative therapies as quickly as possible.

In contrast, options that involve medications not addressing urgent health issues, those with significant safety concerns, or drugs developed through traditional methods do not typically qualify for expedited reviews. These circumstances may not demonstrate sufficient urgency or breakthrough innovation necessary to warrant a faster process, which is the core rationale behind expedited review programs.