FDA’s Center for Drug Evaluation and Research (CDER) has launched its new Accelerating Rare Disease Cures (ARC) Program to accelerate the development of safe and effective treatments for patients with rare diseases, totaling over 30 million in the U.S. The ARC Program will address some of the following complexities:
- Challenges with well-established trial designs
- Endpoint selection with a limited understanding of the natural history of the disease
- Performing and interpreting rare disease clinical trials with small patient populations
View the announcement video video and then visit the FDA announcement page for more information about the ARC’s mission and first year plans.