FDA Launches Program To Boost Development Of Rare Disease Drugs

FDA’s drug center on Tuesday (May 10) launched an Accelerating Rare disease Cures (ARC) Program that aims to speed development of rare disease therapies by strengthening partnerships with stakeholders and overcoming hurdles in rare disease drug development. Both FDA and lawmakers have looked at ways to boost rare disease drug development, including through FDA’s accelerated approval pathway, and House lawmakers have included rare disease-focused measures in their user fee legislation. Drug development for the approximately 7,000 rare diseases and conditions...