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The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.
FDA announced on May 10, 2022 that its Center for Drug Evaluation and Research (CDER) has launched a new program to increase and speed up the development of treatments for unmet needs of patients with rare diseases. The program, which will be managed by CDER’s Rare Diseases Team, will use CDER’s expertise to coordinate activities involved in the treatment of rare diseases.
According to FDA, development of treatments for rare diseases is complex, and using well-established trial designs and endpoint selection can be challenging because of the limited understanding of these conditions. The Accelerating Rare disease Cures (ARC) program will support the development and approval of these treatment options through scientific and regulatory engagement.
“CDER is optimistic about the future of rare disease drug development and is looking forward to continuing this important work under the new CDER ARC Program—together with patients, advocacy groups, academics, industry, and other partners—to address the significant unmet needs of patients and families living with rare diseases,” the agency stated in a press release.