Accessing the Accelerated Approval Pathway for Rare Disease Therapeutics April 07, 2016 Share this page Improvements must be made to the qualification process for biomarkers as primary endpoints in pivotal clinical studies of treatments for the rarest of diseases Accelerated Approval Related Articles The EveryLife Foundation Submits Comments to Support Patient-Focused Drug Development and Medical Innovation July 01, 2026 FDA Rare Disease Roundtable – June 3, 2026 June 04, 2026 EveryLife Foundation Highlights Rare Disease Regulatory Recommendations and the Community’s Eagerness to Work with FDA’s New Leadership May 29, 2026 See All News