FDA Launches Program To Facilitate Rare Disease Drug Development

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has launched a new program, the Accelerating Rare disease Cures (ARC) Program, to facilitate the development of drugs/treatments for rare diseases.

The program will provide collective expertise and activities to provide a strategic overview and coordination of CDER’s rare-disease activities in order to enhance scientific and regulatory innovation and engagement to accelerate the availability of drug/treatments for rare diseases. It is governed by leadership from across several CDER offices: the Office of the Center Director, the Office of New Drugs, and the Office of Translational Sciences. The program is managed by CDER’s Rare Diseases Team.

In its first year, the ARC program will focus on strengthening internal and external partnerships with stakeholders and will engage with external experts to help identify solutions for development of drugs/treatment for rare diseases.

Source: US Food and Drug Administration