Fast Track Authority
Fast Track Authority is a special process that allows the U.S. Food and Drug Administration (FDA) to expedite the review of drugs and treatments that address serious conditions or unmet medical needs. This program aims to bring important therapies to patients more quickly, especially when there are limited or no existing options available.
To qualify for Fast Track Authority, a drug must show potential to significantly improve treatment outcomes. The process includes more frequent communication between the FDA and the drug developers, allowing for a more efficient review and approval process. This initiative is part of the FDA's broader efforts to enhance patient access to innovative therapies.