Which FDA review category includes drugs with faster review times compared to standard applications?

The category that includes drugs with faster review times compared to standard applications is Priority Review. This designation is granted by the FDA to drugs that offer significant advantages over existing therapies, such as improved efficacy or safety for treating serious conditions. By designating a drug for Priority Review, the FDA aims to expedite its review process, often shortening the review time from the standard ten months to six months.

This approach is part of the FDA's effort to facilitate timely access to important new medications that can significantly impact patient health. Priority Review is especially relevant for treatments that address unmet medical needs, ensuring that patients have quicker access to potentially life-saving therapies.

While several other categories exist, such as Standard Review, Accelerated Review, and Expedited Review, they do not specifically define a faster review time in the same manner as the Priority Review designation does. Standard Review follows the typical timeline, and both Accelerated and Expedited are terms that might describe certain pathways but do not explicitly refer to the accelerated review schedule like Priority Review does.