Accelerated approval pathway

The Accelerated Approval Pathway is a regulatory process used by the FDA to expedite the approval of drugs that address serious conditions and unmet medical needs. It allows drugs to be approved based on early evidence that suggests they may be effective, rather than waiting for full clinical trial results. This pathway aims to make promising treatments available to patients more quickly, while still requiring that the drug's benefits are confirmed in later studies. It balances the urgency of patient needs with the need for safety and effectiveness validation.