fast track designation

Fast Track designation is a process used by regulatory agencies, like the FDA, to expedite the development and review of drugs that address serious or life-threatening conditions and have the potential to fulfill unmet medical needs. This status allows for earlier interaction with regulators, quicker assessments, and a more flexible development pathway. The goal is to bring promising treatments to patients faster while maintaining safety and effectiveness standards, ultimately accelerating access to innovative therapies for urgent medical conditions.