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Don’t Call It A Center Of Excellence: Accelerating Rare Disease Cures Program Launched By CDER

 
• By Derrick Gingery

‘Umbrella’ program is intended to ensure all rare disease and related programs at CDER are working together, which seems similar to the rare disease center of excellence concept that stakeholders want to coordinate activities across the FDA.

umbrella organization
The Accelerating Rare Disease Cures (ARC) program is intended to be an umbrella that coordinate rare disease activities in CDER. • Source: Shutterstock

The new Accelerating Rare Disease Cures program at the US Food and Drug Administration may be as much about relieving external pressure to make a more drastic reorganization than about coordinating rare disease activities.

The ARC program, which rests in the Center for Drug Evaluation and Research, is intended to speed development of rare disease treatments and coordinate all work that could affect rare...

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