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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.
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.
In this article, we discuss several challenges in rare disease drug development and why the need for innovation in this space is even more critical than for more common diseases.
In May 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) announced the launch of a new program for expediting the development of...
In May 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) announced the launch of a new program for expediting the development of new treatment options for rare diseases—Accelerating Rare disease Cures (ARC) Program.1 The FDA considers a disease that affects fewer than 200,000 people in the U.S. a rare disease, and estimates that more than 30…