Drugs

Accelerated Rare Disease Cures Program Strategic Plan Out

FDA has published the Accelerated Rare disease Cures (ARC) program strategic plan covering 2025-2030. The document outlines the vision, mission, and programmatic goals for the five years. “The plan details the specific outcomes, expected results, and related strategies on which ARC’s leadership and the rare disease community will strive to work collaboratively to advance rare disease drug development and increase access to safe and effective therapies that improve the lives of patients,” it says.

The strategic plan is organized in four sections:

CDER’s rare disease landscape;
ARC’s role within CDER;
ARC’s strategic components; and
ARC’s goals and objectives.

The program’s strategic goals are:

scientific and regulatory innovations — providing strategic direction and driving the development of regulatory and scientific tools to support rare disease drug development;
engagement and education — to engage with the rare disease community to leverage expertise and innovation, strengthen dialog and understanding of the regulatory framework, and promote effective collaboration; and
operations—to ensure that CDER staff have the scientific expertise and capacity to foster a culture of innovation to advise, support, and advance successful rare disease drug development.

Each goal has strategic objectives listed in the plan.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome