In which scenario is a Priority Review granted by the FDA?

A Priority Review is granted by the FDA for drugs that represent an advance over available therapy. This designation is intended to facilitate the review of drugs that could significantly improve the treatment, diagnosis, or prevention of serious conditions when compared to existing options. The aim is to expedite the approval process for these therapies, enabling faster access to potentially life-saving treatments for patients.

In this context, drugs that offer substantial improvements in efficacy, safety, or convenience over current therapies can qualify for this accelerated review process. The FDA evaluates drugs for Priority Review based on their potential impact on public health, making it a critical designation for innovative treatments.

Other scenarios, such as requiring extensive post-marketing studies or being routine applications without significant changes, do not align with the criteria for Priority Review. Similarly, devices subject to periodic audits are also not applicable since the Priority Review designation specifically pertains to drugs that can provide significant advances in therapeutic options. Thus, the focus is always on how the drug can enhance patient care, which is fundamental to the Priority Review process.