How can accelerated approval and priority review speed the review of certain new drugs?

To expedite the availability of new medications for serious conditions, the U.S. Food and Drug Administration utilizes specific regulatory mechanisms to accelerate the development and review process.1

Accelerated Approval

Accelerated approval is designed to speed the approval of drugs that address unmet medical needs. It allows the FDA to grant approval based on a surrogate endpoint—such as a laboratory measurement or physical sign—that is reasonably likely to predict clinical benefit, rather than waiting for the completion of long-term clinical trials that measure direct clinical outcomes.1

Priority Review

Priority review focuses on the timeline of the regulatory assessment. When a drug is granted this designation, the FDA commits to advancing the application for review within six months of submission, significantly faster than the standard review timeline.1

These mechanisms are essential for ensuring that innovative therapeutics reach patients with life-threatening or serious diseases as quickly as possible, provided that the scientific data continues to support the drug's safety and effectiveness.1