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FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies

FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies

The FDA is announcing the opportunity for a limited number of sponsors to participate in a pilot program allowing for more frequent communication with FDA staff to provide a mechanism for addressing late-phase product development issues.

Accelerating Rare disease Cures (ARC) Program Emerges as a Conduit for Empowering Rare Disease Stakeholders

The ARC Program strives to increase the number of treatments by promoting innovative scientific design, providing a deeper understanding of regulatory policies, and engaging with patients and their advocates, and other rare disease stakeholders.

Why the underestimated economic burden of rare diseases could be costing the U.S. trillions of dollars

While rare diseases impact a small population, the cost to society is staggering. It may be in the range of $7.2-$8.6 trillion per year.